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Summary of Findings: Link to Presentation

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Summary of Findings: Link to Presentation

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Biosimilar: a drug that is chemically and/or functionally similar to another FDA-approved biological.

Given Tirzepatide's recent FDA approval, the drug currently has no biosimilars.

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Eli Lilly is studying N3pG-Ab Monoclonal Antibody: a large molecule that binds to the amyloid plaques in the brain, which are a primary cause of Alzheimer’s Disease. Currently under regulatory review.

(Zhabska, 2021)

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Insulin filled pen that releases medication using Bluetooth attachment and mobile app. Currently under regulatory review.

(Med-Tech, 2021)

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Following the overwhelming success from the completed SURPASS trials, two additional trials SURPASS trials are in the works to further reinforce Tirzepatide's Effectiveness.

SURPASS-6: Expected to be completed by November 2023, and evaluates if Tirzepatide can function as an alternative to prandial insulin (insulin taken during a meal) in Type 2 Diabetics who already use a basal insulin.

SURPASS-COVT: This trial is expected to be completed by October 2024, and evaluates any cardiovascular risk associated with continued use of Tirzepatide.

SURMOUNT-3: Expected to be completed by May 2023, this trial assesses the value of Tirzepatide in helping obese patients improve on and maintain their weight loss during a lifestyle intervention.

(McDermid, 2022)

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                                    Eli Lilly's Pipeline

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                                    Eli Lilly's Pipeline

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Part of Tirzepatide's success is attributed to its thorough testing in clinical trials.

SURPASS-1: Tirzepatide vs. Placebo

SURPASS-2: Tirzepatide vs. Ozempic

SURPASS-3: Tirzepatide vs. Insulin Degludec

SURPASS-4: Tirzepatide vs. Insulin Glargine

SURPASS-5: Tirzepatide vs. Insulin Glargine (w/ and w/o Metformin)

SURMOUNT 1 & 2:  Evaluating Tirzepatide's effectiveness in facilitating weight loss in obese patient without diabetes.

All completed trials demonstrate Tirzepatide's superior ability to achieve greater declines in HbA1c levels as a primary endpoint, with significant decreases in weight seen at all levels.

(Lokuwithana, 2021)

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"A New Drug Application (NDA) tells the full story of a drug. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied. A drug developer must include everything about a drug—from preclinical data to Phase 3 trial data—in an NDA." - FDA Drug Review Step 4

(fda.gov, n.d.)

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Tirzepatide has the longest half life, which necessitates less frequent drug administrations and long-lasting effects.

Tirzepatide is the most expensive, which is a barrier to lower-income patients.

Attributed to mild-to-moderate GI side effects, Tirzepatide has a high number of negative user reviews.

(Drugs.com, n.d.)

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Phase 3, 52 week, multi-site, randomized, parallel-group study

1444 adults

5/10/15 mg Tirzepatide vs 1x/day  subcutaneous injection of titrated insulin degludec

Primary Endpoint: HbA1c change from baseline measurements

Secondary Endpoint: Weight change

At the end of 52 weeks, all doses of Tirzepatide achieved greater declines in HbA1c levels and negative bodyweight changes. The Tresiba treatment group saw an increase in bodyweight. There were also lower incidences of hypoglycaemia in the Tirzepatide treatment groups.

(Ludvik, et al. 2021)

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Tirzepatide vs Competitors & Alternatives

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Tirzepatide vs Competitors & Alternatives

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Tirzepatide vs Ozempic, Its Biggest Competitor

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Tirzepatide vs Ozempic, Its Biggest Competitor

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International, randomized, open label, 40-week comparative study

1879 adults with Type 2 Diabetes

5/10/15 mg Tirzepatide vs 1 mg Ozempic

Primary endpoint: ΔgGycated hemoglobin

Secondary Endpoint: Weight change

All doses of Tirzepatide achieved greater declines in glycated hemoglobin and negative weight change.

(Frias, et al. 2021)

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"Fast Track Designation accelerates tirzepatide's U.S. FDA submission for the treatment of adults with obesity, or overweight with weight related comorbidities"

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Tirzepatide was FDA approved as a dual-incretin Type-2-Diabetes drug on May 13th, 2022.

Given the overwhelming success observed in clinical trials, Tirzepatide was was approved for a Fast Track Designation on October 6th, 2022 as an anti-obesity drug.

Eli Lilly will also submit a New Drug Application following results on a rolling basis from SURMOUNT-1 and SURMOUNT-3 clinical trials.

(Eli Lilly and Company, n.d.)

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(Ali. et al., 2022)

Risk of Thyroid C-Cell Cancer

In a two-year study on both male and female rats, there was a dose- and duration-dependent increase in the incidence of Thyroid C-Cell adenomas and carcinomas.

Further testing is required to determine the risk in humans.

Individuals with a personal history of medullary thyroid carcinoma (MTC), or have a family member with MTC, are advised to be especially cautious.

To mitigate against any negative side effects, MTC patients and those at-risk should monitor their calcitonin values.

Hypoglycaemia (when taken with Insulin or Insulin Secretagogues)

Insulin Secretagogues are orally administered medicines that promote insulin release from beta cells. ex. sulfonylurea.

When insulin or secretagogues are taken simultaneously with Tirzepatide, this can cause severe hypoglycaemia.

This can be prevented with an adjusted (lowered) dose of the secretagogue and insulin.

Kidney Injury

Gastrointestinal side effects include nausea, vomiting, and diarrhea.

Dehydration from these symptoms can cause renal damage.

GLP-1 receptor agonists have been previously shown to worsen symptoms of chronic renal failure, necessitating dialysis.

Individuals with a history of chronic renal failure or gastrointestinal issues should monitor their renal function when they are taking Tirzepatide.

Hypersensitivity

Tirzepatide can cause eczema and urticaria, which can escalate to severe reactions.

GLP-1 receptor agonists have previously been shown to cause hypersensitivity, so those prone to these reactions must monitor their responses to Tirzepatide.

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"Lilly has a nearly 100-year heritage of advancing care for people living with diabetes – never settling for current outcomes... We are thrilled to introduce Mounjaro, which represents the first new class of type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the diabetes community." - Mike Mason, president, Lilly Diabetes. 

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"Lilly has a nearly 100-year heritage of advancing care for people living with diabetes – never settling for current outcomes... We are thrilled to introduce Mounjaro, which represents the first new class of type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the diabetes community." - Mike Mason, president, Lilly Diabetes. 

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Eli Lilly drug tirzepatide meets weight-loss goals in obesity trial

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Tirzepatide not only takes advantage of the increasingly lucrative markets of Anti-Obesity and Type 2 Diabetes, it serves as the FIRST and ONLY dual incretin GIP and GLP-1 treatment.

With a proven superior performance over all of its competitors, this drug takes advantage of the body’s natural incretin hormone receptors to act as a universal treatment for patients around the globe.

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Tirzepatide is More Powerful Than Intended!

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Tirzepatide is More Powerful Than Intended!

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Although weight loss was not on the researchers' radar in preclinical studies, you will come to learn in the next section that it was an extremely significant side effect observed in clinical trials. The weight loss data was so convincing that Eli Lilly branded Tirzepatide for an additional application: obesity treatment. This story demonstrates that preclinical trials are truly just a screening phase to determine the basics; and that further testing is essential - you'll never know what you might find!

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(Morgan Stanley, 2022) & (Precedence Research, 2021)

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Financial Benefit of Developing Tirzepatide (Kansteiner, 2022) & (Precedence Research, 2021)

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Financial Benefit of Developing Tirzepatide (Kansteiner, 2022) & (Precedence Research, 2021)

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90% to 95% of the 330 million new cases of diabetes in 2022 will be type 2 diabetes. Additionally, children and adolescents are more susceptible to type 2 diabetes. As a result, the increasing number of patients with type 2 diabetes is driving the expansion of the worldwide type 2 diabetes market. The market size for type-2 diabetes is anticipated to reach $61.6 billion by 2030. Moreover, the governments of emerging nations offer tax advantages and subsidies to the producers of type 2 diabetes treatments and therapies. All of these reasons contribute to the expansion and growth of the global type 2 diabetes market.

Obesity is predicted to become the "next blockbuster pharma category". As obesity becomes more prevalent, researchers predict that over time, 25% of persons with obesity will consult with doctors about their condition, up from 7% presently. As a result, approximately 55% of those individuals will be administered a new anti-obesity medicine.

Due to the fact that tirzepatide is the first and only dual target medicine, Eli Lilly is predicted to have approximately 40% share in the obesity market and earn more than $54 billion in 2030 with tirzepatide. The only competitor Eli Lilly has is Wegovy from Novo company.

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Potential Impacts of Tirzepatide (Ciccone, 2022)

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Potential Impacts of Tirzepatide (Ciccone, 2022)

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Tirzepatide has shown many potential impacts on patients. First of all, patients taking tirzepatide show significantly increased control of their blood glucose levels. Weight loss also came in when taking tirzepatide as a beneficial side effect. In addition, people taking tirzepatide have also been shown to have a higher quality of life as they feel more comfortable getting up and down from the ground, standing, and even doing strenuous physical activity. Studies have also shown that people taking tirzepatide have a lower risk of getting cardiovascular diseases. More importantly, it has the potential to replace surgery for obese patients in the near future.

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Introduction - Thea Zeng
Drug Development - Eloise Valasek
Clinical Trials - Ashlyn Nance
Analysis and Future Outlook - Anna Samuel

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6ixBuzzTV. 2022. Instagram com. [Accessed 2022 Nov 25] https://www.instagram.com/

Ali R, Virendra SA, Chawla PA. 2022. Bumps and humps in the success of Tirzepatide as the first GLP1 and GIP receptor agonist. Health Sciences Review. 4(100032):100032. doi:10.1016/j.hsr.2022.100032. https://www.sciencedirect.com/science/article/pii/S2772632022000216.

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Chavda VP, Ajabiya J, Teli D, Bojarska J, Apostolopoulos V. Tirzepatide, a new era of dual-targeted treatment for diabetes and obesity: A mini-review. Molecules. 2022;27(13):4315. doi:10.3390/molecules27134315

Ciccone I. Next-level efficacy: Mounjaro. PharmExec. 2022 Sep 9 [accessed 2022 Nov 28]. https://www.pharmexec.com/view/next-level-efficacy-mounjaro

Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, et al. Ly3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Molecular Metabolism. 2018;18:3–14. doi:10.1016/j.molmet.2018.09.009

CSIMarket > Company S. LLY's vs. market share relative to its competitors, as of Q3 2022. CSIMarket. 2022 Nov 13 [accessed 2022 Nov 29]. https://csimarket.com/stocks/competitionSEG2.php?code=LLY

Donanemab shows benefit in phase II alzheimer's study - physician's Weekly. Physician's Weekly - A trusted source of medical information for healthcare professional. 2021 Mar 16 [accessed 2022 Nov 29]. https://www.physiciansweekly.com/donanemab-shows-benefit-in-phase-ii-alzheimers-study

Eli Lilly Drug Tirzepatide meets weight-loss goals in obesity trial. YouTube. 2022 Apr 28 [accessed 2022 Nov 29]. https://www.youtube.com/watch?v=jg53mXSszQY&t=1s&ab_channel=CNBCTelevision

Eli Lilly - 50 year stock price history: LLY. Macrotrends. 2022 [accessed 2022 Nov 29]. https://www.macrotrends.net/stocks/charts/LLY/eli-lilly/stock-price-history

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FDA approves Lilly's mounjaro™ (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. Eli Lilly and Company. 2022 May 13 [accessed 2022 Nov 29]. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and

Frias JP, Nauck MA, Van J, Kutner ME, Cui X, Benson C, Urva S, Gimeno RE, Milicevic Z, Robins D, et al. Efficacy and safety of Ly3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: A randomised, placebo-controlled and active comparator-controlled phase 2 trial. The Lancet. 2018;392(10160):2180–2193. doi:10.1016/s0140-6736(18)32260-8

Glooko and Eli Lilly collaborate over connected insulin pens. Med. 2021 May 7 [accessed 2022 Nov 29]. https://www.med-technews.com/news/Digital-in-Healthcare-News/glooko-and-eli-lily-collaborate-over-connected-insulin-pen-s/

Gubar M, von Reuss T, Burkhanayev T. 2022 May 17. Mounjaro: New dual-action drug for type 2 diabetes mellitus. BioPharma Media. [accessed 2022 Nov 30]. https://biopharma.media/mounjaro-new-dual-action-drug-for-type-2-diabetes-mellitus-1852/.

Highlights of Prescribing Information (tirzepatide) Injection, for subcutaneous use Initial U.S. Approval: 2022. Fda.gov. [accessed 2022 Nov 30]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf.

Lilly receives U.S. FDA Fast Track designation for Tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. Eli Lilly and Company. 2022 Oct 6 [accessed 2022 Nov 29]. https://investor.lilly.com/news-releases/news-release-details/lilly-receives-us-fda-fast-track-designation-tirzepatide#:~:text=Tirzepatide%20was%20approved%20as%20Mounjaro,FDA%20on%20May%2013%2C%202022%20.

Ludvik B, Giorgino F, Jódar E, Frias JP, Fernández Landó L, Brown K, Bray R, Rodríguez Á. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (surpass-3): A randomised, open-label, parallel-group, phase 3 trial. The Lancet. 2021;398(10300):583–598. doi:10.1016/s0140-6736(21)01443-4

Lokuwithana D. Lilly's tirzepatide studies achieve primary and secondary endpoints. SeekingAlpha. 2021 Feb 17 [accessed 2022 Nov 29]. https://seekingalpha.com/news/3662856-lillys-tirzepatide-studies-achieve-primary-and-secondary-endpointe

McDermid AE. A quick guide to the surpass and surmount trials. diabetes.medicinematters.com. 2022 Aug 10 [accessed 2022 Nov 29]. https://diabetes.medicinematters.com/tirzepatide/type-2-diabetes/a-quick-guide-to-the-surpass-and-surmount-trials/18478154

Mikulic M. Eli Lilly Top Products by revenue 2020-2021. Statista. 2022 Feb 24 [accessed 2022 Nov 29]. https://www.statista.com/statistics/278214/eli-lilly-and-companys-top-products-based-on-revenue/

Min T, Bain SC. 2021. The role of tirzepatide, dual GIP and GLP-1 receptor agonist, in the management of type 2 diabetes: The SURPASS clinical trials. Diabetes Ther. 12(1):143–157. doi:10.1007/s13300-020-00981-0. [accessed 2022 Nov 30]. https://pubmed.ncbi.nlm.nih.gov/33325008/.

Mounjaro alternatives compared. Drugs.com. [accessed 2022 Nov 29]. https://www.drugs.com/compare/mounjaro

Moura FA, Scirica BM, Ruff CT. 2022. Tirzepatide for diabetes: on track to SURPASS current therapy. Nat Med. 28(3):450–451. doi:10.1038/s41591-022-01733-2. [accessed 2022 Nov 30]. https://www.nature.com/articles/s41591-022-01733-2.

Nauck MA, D’Alessio DA. 2022. Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regarding glycaemic control and body weight reduction. Cardiovasc Diabetol. 21(1):169. doi:10.1186/s12933-022-01604-7. http://dx.doi.org/10.1186/s12933-022-01604-7.

Obesity and overweight. World Health Organization. 2021 Jun 9 [accessed 2022 Nov 29]. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight

Obesity Drugs: The next blockbuster? Morgan Stanley. 2022 Aug 9 [accessed 2022 Nov 29]. https://www.morganstanley.com/ideas/obesity-drugs-investment-opportunity

Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (surpass-1): A double-blind, randomized, phase 3 trial. The Lancet. 2021;398(10295):143-155. doi:10.1016/s0140-6736(21)01324-6

Type 2 diabetes market (by drug class: Dipeptidyl peptidase-4, inhibitors, glucagon-like peptide, receptor agonists, thiazolidinediones, alpha-glucosidase inhibitors, sulfonylureas, secretagogues, biguanides, sodium glucose cotransport 2 inhibitors; by Application: Hospital Pharmacies, retail pharmacies, online pharmacies, others) - global industry analysis, size, share, growth, trends, Regional Outlook, and forecast 2022 – 2030. Precedence Research. [accessed 2022 Nov 29]. https://www.precedenceresearch.com/type-2-diabetes-market

Vitek R. Lessons from Lilly's Prozac patent case. Bizjournals.com. 2000 Oct 2 [accessed 2022 Nov 28]. https://www.bizjournals.com/triangle/stories/2000/10/02/smallb4.html

YouTube; 2016. https://www.youtube.com/watch?v=FZ0MKnQ4g64

YouTube; 2022. https://www.youtube.com/watch?v=691XE7poYbY

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We can determine that there were many improvements in these patients' glycemic control and bodyweight, and there was no increase in risk of developing hypoglycemia. Meaning, from phase one to phase three Tirzepatide has had positive effects on all of the participants' glycemic control making this product an extremely effective treatment for type 2 diabetes.

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Strengths

Clear baselines and measurements were displayed

Large group size increasing the studies statistical significance

Weaknesses

No concrete graphs are representing the data, only tables. To strengthen the results figures would be extremely helpful.

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This figure shows the deviations from the baselines observed. They all proved to be statistically significant with the highest dose of Tirzepatide having the greatest overall impact.

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705 individuals were assessed, 478 selected, 231 were women, 121 on 5mg, 121 on 10mg, 121 on 15 mg, 115 on placebo, and 118 participants ended the study early.

At 40 weeks all of the different doses proved to be more effective than the placebo. Meaning, there were negative deviations from the baselines (HbA1c, fasting serum, glucose and bodyweight). This finding is observed in Figure 7.

Some side effects were noticed, however, they were mainly moderate to mild nausea, diarrhea and vomiting.

Therefore, we can determine that there were many improvements in these patients' glycaemic control and bodyweight, and there was no increase in risk of developing hypoglycemia.

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Brief overview of clinical trials data

Mounjaro (different doses) vs placebo (SURPASS-1)

This was a 40 week, double blind, placebo controlled, phase 3 trial of this drug.

52 medical research centers participated in this study and all participants were masked to treatment assignment.

Randomized 478 patients diagnosed with type 2 diabetes carrying inadequate glycemic control.

Selected participants were given a treatment including diet and exercise also received a dose of 5mg, 10mg, 15mg or placebo.

Primary goal was to show the effectiveness of the drug compared to the placebos.

The effectiveness is displayed through the change from the baseline in A1C (glycated hemoglobin) at the 40 week check point and was then compared with the effectiveness between A1C < 7% and <5.7%.

Including the changes in fasting serum glucose and weight change

Mean baseline of A1C: 7.9% (observed in Figure X)

Mean T2D duration of 47 years

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Strengths

Thorough baseline observations to allow for understanding of a variety of variables that could affect the patient's internal chemistry.

Excellent use of figures to provide clear understanding

Relatively large study group considering the short trial period.

Clear pre clinical trial methodology

Weaknesses

Short trial period

No in depth analysis of the confounding variables in this study

Exclusion criteria was not clear

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Strengths

In depth study profile provided

Figures are clear and understandable

Large trial group

Long trial period

Weakness

Confounding variables are present in the study, but barely considered

Goal of this study could be expressed in clearer language

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There were significant changes in the participants' body weight. This ranged from a 0.9 kg to 11.3 kg loss in weight. All doses decreased body weight relative to the dose. For example, the participants taking the 15mg dose had the greatest average weight loss. There was also an observed lower concentration of cholesterol in the dose patients.

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Figure 5b shows that there was a statistically significant reduction in the HbA1c (hemoglobin A1c) with the 5mg, 10mg, and 15mg doses in comparison to both the dulaglutide and the placebo. However, 10mg and 15 mg had the greatest effect on the hemoglobin A1c levels (the greatest glycemic effect). At the 26 week checkpoint 33 - 90% of patients treated with the doses reached their target of less than 7% hemoglobin A1c levels. These numbers are also observed in Figure 5c, showing the proportions of participants hitting each of the target percentages.

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Methods

318 Participants with T2DM

26 week placebo controlled double blind

Followed by a 4-week safety follow up

Doses

Fixed

1 mg

5 mg

Titration Doses

5/10 mg

5/10/15 mg

Dulaglutide

1.5 mg

Placebo Group

Exclusion and participant selection (the study profile) is displayed in Figure 2.

Measurements

Observed different deviations from the mean baselines originally collected. These main baselines are HbA1c, weight, and fasting plasma glucose concentration. The observations of each main baseline are visible in Figure 3.

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Results

Body Weight

There was a substantial decrease in weight that was observed. The Placebo group showed little fluctuations in weight and varying on the dose given there were -0.7% - -2.95% deviations from the baseline. This can be observed in Figure 1a.

Fasting Glucose Change/ Glycaemic Control

Fasting glucose showed a significant decrease in both of the titration groups that were measured compared to the placebo on day 23. This can be observed in Figure 1b.

Average Glucose Levels

Monitored on Day 23 and measured the average after 2 hours.

A significant decrease in glucose response was observed across all of the doses, except the 0.5mg fixed dose, compared to the placebo. This is observed in Figure 1c.

Average Insulin Levels

Monitored on Day 23 and measured the average after 2 hours.

Insulin levels during this examination showed an extremely positive response in the second titration group compared to the placebo dose. This can be analyzed in Figure 1d.

7-Point SMBG

The figure is representative of the titration group 2, and observed 2 days before the experiment, day 8 of the experiment, day 15 of the study, and day 22 of the study.

The findings remained consistent and showed a dose dependent reduction in the postprandial glucose at the varying checkpoints in the study. This finding is represented in Figure 1e.

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Figure 1

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Methods

53 Participants with Type 2 Diabetes

5 Different trial groups

Two Fixed Doses

0.5 mg and 5 mg

Two Titration groups

0.5/5/10 mg

0.5/5/10/15 mg

Titration drug group one begins with a 0.5mg treatment and after a couple days they would increase to 5 mg then to 10mg

Placebo Group

4 week treatment period

4 week follow up period

Measurements

Assessed changes in Hb1A1c, fasting glucose, fasting insulin, body weight, 7-point self-monitored blood glucose blood glucose profiles, and glucose and insulin response following an oral glucose tolerance test (OGTT).

7-Point SMBG profile data are presented on Days 2 (prior to administration of study drug), 8 (after the second dose), 15 (after the third dose), and 22 (after the fourth dose).

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(Rosenstock et al. 2021)

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(Frias et al. 2018)

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(Coskun et al. 2018)

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In the early 2010s, Eli Lilly and Co started designing Tirzepatide's preclinical trials. Their goal was to design a comprehensive study that tested all relevant potential risks. 

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In the early 2010s, Eli Lilly and Co started designing Tirzepatide's preclinical trials. Their goal was to design a comprehensive study that tested all relevant potential risks. 

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Dosage and toxicity: In a 2-year study, both female and male rats were delivered 0.15, 0.5 or 1.5 mg/kg of Tirzepatide twice weekly by subcutaneous injection. Female and male rabbits were also included in the study, but they were dosed at 0.01, 0.03, or 0.1 mg/kg.

Unexpected surprise: In rats for all dosage categories, thyroid C-cell tumours formed. These tumours were dose-dependent and treatment-duration dependent. The risk to humans is unknown and disclosed.

Tumorigenicity: Deemed not significant. In a 6-month toxicology study done with mice, the administered doses of 1, 3 and 10 mg/kg were not tumorigenic.

Effects on fertility: Twice weekly subcutaneous injections of 0.5, 1.5 or 3mg/kg yielded no consequences on fertility in male rats. In female rats, injections decreased viable embryos and mean implantation site numbers.

Mutagenesis: Deemed not significant. Tirzepatide was not found to be genotoxic in tests using rat bone marrow micronucleus assays.

Effects on pregnancy: In both pregnant rats and rabbits, fetal abnormalities occurred. The current recommendation to humans stands as such: “should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”

(accessdata.fda.gov, 2022)

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1. Assess the toxicity of the molecule
2. Avoid human loss due to adverse and unforeseen effects
3. Generate data for in-human-use application

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The Urgency to Solve Diabetes and Obesity! (World Health Organization, 2022)

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The Urgency to Solve Diabetes and Obesity! (World Health Organization, 2022)

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Diabetes is a chronic, metabolic condition defined by high levels of blood glucose (or blood sugar), which causes catastrophic damage to the heart, blood vessels, eyes, kidneys, and nerves over time. About 422 million people have diabetes. The most prevalent is type 2 diabetes, which mainly affects adults and arises when the body develops insulin resistance or fails to produce enough insulin. The prevalence of type 2 diabetes has grown rapidly in nations of all economic levels during the last three decades. For people with diabetes, an effective drug to control their symptoms is critical for their survival.

Aside from diabetes, obesity is also a prevalent disease that is highly linked to diabetes. In fact, obesity is a major risk factor for diabetes, and Obese people are six times more likely to develop diabetes.

The European Commission categorized obesity as a chronic condition last year, with the area now "on the edge of shifting into mainstream primary care management."

Obesity has developed as a prominent global health concern over the last century as a result of recent environmental. Obesity prevalence has roughly doubled globally since 1980. In 2014, more than 39% of adults aged 18 and up were overweight, with 13% being obese. Furthermore, according to the World Health Organization, at least 41 million children under the age of five are overweight or obese.

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Eli Lilly's Top Best-Selling Drugs by Revenue 2020-2021

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Eli Lilly's Top Best-Selling Drugs by Revenue 2020-2021

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•The best-selling drug by revenue is Trulicity, a type 2 diabetes treatment.
• The Top 8 best-selling drugs by revenue are Trulicity, Humalog, COVID-19 antibodies, Taltz, Alimta, Jardiance, Verzenio, and Humulin.
•Out of the top eight best-selling drugs, four of them are diabetes medicine.

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In 2021, Trulicity was Eli Lilly's biggest revenue generator with about 6.5 billion U.S. dollars. The next highest revenue generating drug in 2021 was Humalog with about 2.5 billion U.S. dollars. Eli Lilly is a multi-national pharmaceutical company that is headquartered in Indianapolis, Indiana.

Eli Lilly Company

Eli Lilly was founded in 1876 in the United States. As of today, the company has almost 35 thousand employees globally. The company specializes in global health initiatives, diabetes care and a multitude of other products concerning human health. Eli Lilly currently markets products in over 120 countries globally. As of 2018, the company was among the top pharmaceutical companies based on both prescription sales and research and development spending.

Diabetes products by Eli Lilly

Eli Lilly is the manufacturer of several of the global top diabetic pharmaceutical products and treatments. As of 2017, Eli Lilly was the second top seller of anti-diabetic pharmaceuticals based on revenue. Globally, Trulicity, one of Eli Lilly's top drugs used in the treatment of type II diabetes, is projected to be the top anti-diabetic pharmaceutical by the year 2024.

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Eli Lilly top products by revenue 2020-2021 | Statista

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In 2021, Trulicity was Eli Lilly's biggest revenue generator with about 6.5 billion U.S. dollars. The next highest revenue generating drug in 2021 was Humalog with about 2.5 billion U.S. dollars. Eli Lilly is a multi-national pharmaceutical company that is headquartered in Indianapolis, Indiana. Eli Lilly was founded in 1876 in the United States.

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Eli Lilly Lost Their Patent for Prozac in 2000 (Vitek, 2000)

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Eli Lilly Lost Their Patent for Prozac in 2000 (Vitek, 2000)

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Eli Lilly patented Prozac in January 1974. Eli Lilly filed five more patents on Prozac and how to utilize it to treat disorders between 1982 and 1986. Time expired several patents. Barr Laboratories filed with the FDA in December 1995 to create a "generic" Prozac. It certified that no genuine patent would be infringed.

The appeals court ruled that one Prozac patent overlapped the last.

Eli Lilly stock plunged roughly a third in 2000. After Then, Eli Lilly switched focus to diabetes and obesity!

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Lessons from Lilly’s Prozac patent case - Triangle Business Journal

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The Triangle Business Journal features local business news about Raleigh/Durham. We also provide tools to help businesses grow, network and hire.

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Tirzepatide is the first incretin dual-agonist drug. By addressing the compromised action of GLP-1 and GIP in type 2 diabetic patients, it takes a unique approach at tackling a source mechanism of the disease. Its molecular mechanism is well-researched and this was proven in preclinical trials. The preclinical studies were thorough and proved Tirzepatide was ready for in-human testing, at which point clinical trials began post-IND approval.

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Use synthetic peptides to mimic the incretins and activate their respective receptors to restore the incretin effect. A two-in-one approach!

They created a 39-amino-acid-long synthetic peptide called Tirzepatide that fulfills this function.

The mechanism is low maintenance, addressing the previous problem because it is administered as a single-dose subcutaneous injection, taken once a week at any time of day.

(Nauck and D'Alessio, 2022)

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In the early 2010s, Eli Lilly recognized the need for a new Type 2 diabetes treatment. While insulin and its analogs were well-developed, they require administration multiple times a day and are high maintenance. The company’s idea was to develop an easier-to-manage treatment that targeted the root cause of the condition, rather than an outcome.

In a person with healthy glycemic control, the incretin hormones, glucagon-like peptide 1 and gastric inhibitory polypeptide (GLP-1 and GIP), induce what is called the incretin effect: this refers to the stimulation of beta cells to increase insulin secretion in response to nutrient intake. In patients with T2D, this incretin effect is diminished. Eli Lilly was determined to address the incretin effect deficiency.

(Gubar et al., 2022)

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Tirzepatide, the dual-agonist synthetic peptide, binds the GLP-1 and GIP receptors, activating adenylate cyclase. This causes an elevation of cAMP, and subsequent activation of PKA and the EPAC2 protein.

This signalling cascade causes the KATP and Kv channels to close and membrane depolarization occurs. In response, actions of the voltage-gated calcium channels cause the cellular calcium concentration to rise. The increased calcium concentration signals for the fusing of insulin-containing granules with the plasma membrane, and thus insulin gets released. The insulin release prompts glucose uptake and metabolism.

This sequence of molecular processes increases proinsulin gene transcription and is regulated by EPAC2, among other mechanisms.

(Ali et al., 2022)

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What is Tirzepatide(Mounjaro)?  (Chavda et al., 2022)

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What is Tirzepatide(Mounjaro)?  (Chavda et al., 2022)

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Mounjaro (tirzepatide) is a type-2-diabetes medication developed by Eli Lilly, and it is used in conjunction with diet and exercise to treat persons with type 2 diabetes who are not adequately managed. Tirzepatide is the first and only FDA-approved dual GIP and GLP-1 receptor agonist for diabetes. It is also very easy to use, it can be injected under the skin of the abdomen, upper arm or thigh. In fact, tirzepatide has shown even higher efficacy than Trulicity (the best-selling T2D drug in Eli Lilly) in treating type-2 diabetes. In addition, this first-in-class medication is well tolerated and has a lower side-effect profile than other GLP-1s. Most importantly, Tirzepatide is also the first dual treatment, which can tackle both diabetes and obesity.

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The Recent Unexpected Twist and the Remaining Challenges

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The Recent Unexpected Twist and the Remaining Challenges

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Just recently, following Twitter's new ownership transition, a bogus user posted that Eli Lilly was distributing free insulin. Following the corporation's corrective response, the company experienced backlash for selling products at such a high price point, causing its stock price to plummet dramatically.

This incident reflects a remaining challenge of Eli Lilly and potentially tirzepatide.  Eli Lilly has a high-pricing strategy. Such prices can lead to customer dissatisfaction and loss, as well as prevent others in need from obtaining vital medications.

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Eli Lilly's Unrivalled Advantages (Eli Lilly and Company, 2022)

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Eli Lilly's Unrivalled Advantages (Eli Lilly and Company, 2022)

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1. One of the Biggest Research & Development Departments
• >8,900 employees in R&D
• $7.026 million on research in 2021
• Clinical research conducted in more than 55 countries
• Research and development facilities located in 7 countries

2. Board Marketing Strategy
• Products marketed in 120 countries
• Manufacturing plants located in 7 countries

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Milestones of Eli Lilly (Eli Lilly and Company, 2022)

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Milestones of Eli Lilly (Eli Lilly and Company, 2022)

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• Market Capitalization: US$348.39 Billion (CSIMarket, 2022)

• Market Share of 4.75% relative to its competitors in 2022. (CSIMarket, 2022)

• Stock Price of over US$367, and its stock value has been growing exponentially since 2010.

• Revenue: $28,318 million (Eli Lilly and Company, 2022)

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Who is Eli Lilly? What is Eli Lilly & Co?

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Who is Eli Lilly? What is Eli Lilly & Co?

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Overview: (Eli Lilly and Company, 2022)
Eli Lilly & Co was founded by Colonel Eli Lilly in 1876. with the goal of developing high-quality medications that fulfilled real needs in an era of untrustworthy elixirs peddled by questionable characters. "Take what you find here and make it better and better," he told subsequent generations of staff.

More than 145 years later, Eli Lilly & Co remains dedicated to its mission in all aspects of its business and the people it serves.

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Lilly For Better: From Our Founder to Present

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Above are the observed average percentage of hemoglobin A1c observed in each individual trial group