Tirzepatide for Obesity

Overseen By This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Diabetes, Cardiovascular, Neurological, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tirzepatide (also known as Mounjaro or Zepbound) affects energy use and eating habits in people with obesity. The study aims to determine if this treatment changes the number of calories participants burn and how much they eat. Participants will receive either tirzepatide or a placebo (a substance with no active drug) through weekly injections. Suitable candidates have a stable weight and a body mass index (BMI) between 30 and 45. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken any weight loss drugs in the past 6 months.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Earlier research has generally shown tirzepatide to be well-tolerated by participants. The FDA has approved this treatment for type 2 diabetes, indicating a certain level of safety. For weight management, studies have demonstrated its effectiveness and safety. Most participants experienced mild to moderate side effects like nausea, but these were not serious. As this trial is in an early stage, it focuses on understanding how the treatment works and its safety in people with obesity. The treatment is still under careful study for safety in this new group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tirzepatide is unique because it tackles obesity by mimicking two natural hormones, GLP-1 and GIP, which regulate appetite and energy use. Unlike current treatments that often focus solely on GLP-1, tirzepatide's dual action may lead to better weight loss results. Researchers are excited because this approach could offer a more effective and comprehensive solution for managing obesity. Plus, it's administered once a week via a simple injection, making it convenient for patients.

What evidence suggests that tirzepatide might be an effective treatment for obesity?

This trial will compare tirzepatide with a placebo. Studies have shown that tirzepatide can significantly aid weight loss in people with obesity. In one 72-week study, participants who took tirzepatide weekly lost a substantial amount of weight. More than half of those on higher doses, such as 15 mg, lost at least 20% of their body weight. This treatment not only supports weight loss but also may help prevent diabetes and heart problems. Overall, tirzepatide shows strong promise for effectively treating obesity. ^{4 5 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a body mass index of between 30 and 45 kilograms per square meter, inclusive.

I have not been significantly overweight in the past month.

I am willing to participate in this study for the duration and will follow all instructions from the clinic staff.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive tirzepatide or placebo once weekly by subcutaneous injection

28 weeks

21 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tirzepatide

How Is the Trial Designed?

Group I: 15 Milligram (mg) Tirzepatide Experimental Treatment 1 Intervention

Participants received 15 mg of tirzepatide QW by SC injection.

Group II: Placebo Placebo Group 1 Intervention

Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.

Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Mounjaro for:

• Type 2 diabetes

Approved in European Union as Mounjaro for:

• Type 2 diabetes

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Approved in United States as Zepbound for:

• Weight loss
• Moderate to severe obstructive sleep apnea

Approved in United Kingdom as Zepbound for:

• Weight loss

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Tirzepatide demonstrated a dose-dependent ability to lower HbA1c levels in adults with type 2 diabetes, with reductions ranging from -17.71 to -22.35 mmol/mol compared to placebo, and was also more effective in reducing body weight than other treatments.

While tirzepatide did not increase the risk of hypoglycaemia compared to placebo and showed lower rates than basal insulin, it was associated with a higher incidence of gastrointestinal side effects, particularly nausea and vomiting, especially at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Karagiannis, T., Avgerinos, I., Liakos, A., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, has a safety profile similar to other GLP-1 receptor agonists, but higher doses (10mg and above) are associated with increased risks of hypoglycemia and treatment discontinuation.

In clinical trials involving 9818 patients, higher doses of tirzepatide led to more frequent gastrointestinal side effects like nausea, vomiting, and diarrhea, indicating that these adverse events are dose-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? Meng, Z., Yang, M., Wen, H., et al.[2023]

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

LY3298176, a dual GIP and GLP-1 receptor agonist, demonstrated significant improvements in glycemic control and body weight reduction in both preclinical studies and a Phase 1b trial involving 142 subjects with type 2 diabetes mellitus (T2DM).

The most common side effects were mild to moderate gastrointestinal issues, which were dose-dependent, indicating that while LY3298176 is effective, monitoring for these side effects is important during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Coskun, T., Sloop, KW., Loghin, C., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39996368/

Real-world use and effectiveness of tirzepatide among ... Outcomes were assessed in 3 cohorts: (1) Overall cohort: age ≥18 years; ≥1 tirzepatide claim; no baseline T2D diagnosis codes, anti-diabetes ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04657003

NCT04657003 | A Study of Tirzepatide (LY3298176) in ... This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide ...

4. zepbound.lilly.com zepbound.lilly.com/hcp/clinical-data-weight

Clinical Data, Safety & Study Design | WR - Zepbound - Eli Lilly Powerful reductions in body weight · Proven efficacy at multiple doses · More than half of adults taking Zepbound 10 and 15 mg lost ≥20% of their body weight ...

5. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2831205

Lifetime Health Effects and Cost-Effectiveness of ... Tirzepatide and semaglutide were found to generate greater lifetime health gains by preventing diabetes, cardiovascular complications, and death.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469573/

Real-World Safety Concerns of Tirzepatide ... receptor agonist, is approved for type 2 diabetes and weight management. Despite its efficacy, real-world safety data remain limited. This ...

7. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI Bookshelf Tirzepatide is a novel medication approved by the US Food and Drug Administration (FDA) for treating type 2 diabetes mellitus (T2DM).