LY3841136 + Tirzepatide for Obesity

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eli Lilly and Company

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for healthy individuals without certain conditions, it's best to discuss your specific medications with the trial coordinators.

What data supports the idea that LY3841136 + Tirzepatide for Obesity is an effective treatment?

The available research shows that adding tirzepatide to a lifestyle intervention significantly increased weight loss in adults with obesity. In one study, participants who took tirzepatide lost an average of 18.4% of their body weight over 72 weeks, compared to just 2.5% for those who took a placebo. Additionally, 87.5% of participants on tirzepatide achieved at least a 5% weight reduction, compared to only 16.5% of those on a placebo. This suggests that tirzepatide is much more effective than a placebo in helping people lose weight. ^{1 2 3 4 5}

What safety data is available for LY3841136 + Tirzepatide in treating obesity?

The safety data for tirzepatide, a component of the treatment, shows it is generally well-tolerated with mild to moderate gastrointestinal side effects being the most common. It has been tested in multiple phase 3 trials, such as SURMOUNT-2 and SURPASS 1-5, demonstrating a consistent safety profile similar to other GLP-1 receptor agonists. Tirzepatide has shown potential for weight reduction and improved glycemic control without increased risk of hypoglycemia. However, specific safety data for LY3841136 in combination with tirzepatide is not detailed in the provided research. ^{1 4 6 7 8}

Is the drug LY3841136 a promising treatment for obesity?

The drug LY3841136, when combined with tirzepatide, shows promise for treating obesity. Tirzepatide has been shown to help people lose significant weight, especially when combined with lifestyle changes. This suggests that LY3841136 could be a promising option for those struggling with obesity. ^{1 2 3 4 6}

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

Eligibility Criteria

This clinical trial is for overweight and obese individuals who are interested in testing a new treatment. Specific eligibility criteria to join the study have not been provided, but typically participants must meet certain health conditions.

Inclusion Criteria

I am committed to following the study's procedures for its entire duration.

Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²)

Have clinical laboratory test results within normal reference range

Exclusion Criteria

Have abnormal blood pressure and pulse rate

Have a history or presence of psychiatric disorders

I have diabetes (type 1 or 2).

Treatment Details

Interventions

• LY3841136 (Other)

Trial Overview The trial is evaluating the safety and tolerability of a drug called LY3841136 when used with another medication named tirzepatide. The study will track participant responses over a period of up to 42 weeks.

Participant Groups

Group I: LY3841136 + Tirzepatide Experimental Treatment 2 Interventions

LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.

Group II: Placebo + Tirzepatide Placebo Group 2 Interventions

Placebo administered SC in combination with tirzepatide given SC.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Fortrea CRU, Inc. Madison, WI

Fortrea CRU, Inc. Daytona Beach, FL

Fortrea Clinical Research Unit Daytona Beach, FL

Fortrea CRU, Inc. Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2708

Patients Recruited

3,720,000+

Findings from Research

Tirzepatide, administered once weekly, has been shown to be effective in promoting weight loss in individuals with obesity, as demonstrated in a clinical study.

The treatment not only aids in weight reduction but also improves metabolic health markers, making it a promising option for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[2022]

Tirzepatide, administered once weekly, was found to be effective in reducing obesity in individuals with type 2 diabetes, as demonstrated in a large phase 3 trial involving multiple centers.

The study was double-blind and placebo-controlled, ensuring robust results that support tirzepatide as a promising treatment option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with BMI ≥27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In adults with BMI ≥27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide: A Promising Drug for Type 2 Diabetes and Beyond. [2023]