LY3841136 + Tirzepatide for Obesity

Recruiting at 5 trial locations

Overseen By Nicholas Siebers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Psychiatric disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 42 weeks

96 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves assessing new treatments, it's possible that some medications might need to be paused. Please consult with the study coordinators for specific guidance.

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 data supports the effectiveness of the drug LY3841136 + Tirzepatide for obesity?

Research shows that tirzepatide, a component of the treatment, significantly helps with weight loss in people with obesity, both with and without type 2 diabetes. In studies, people taking tirzepatide lost more weight compared to those who did not, with many achieving substantial weight reduction. ^{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 tirzepatide safe for humans?

Tirzepatide has been shown to be generally safe in humans, with the most common side effects being mild to moderate stomach-related issues. It has been tested in people with type 2 diabetes and obesity, showing a low risk of causing low blood sugar. ^{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}

What makes the drug LY3841136 + Tirzepatide unique for treating obesity?

The drug LY3841136 + Tirzepatide is unique because it combines tirzepatide, which is a novel dual-action medication that targets two hormones involved in blood sugar and appetite regulation, potentially offering more effective weight loss compared to other treatments. Tirzepatide has shown significant weight reduction in people with obesity, both with and without type 2 diabetes, when used alongside lifestyle interventions. ^{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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3841136 and tirzepatide or placebo and tirzepatide for safety and tolerability assessment

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3841136

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.

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

Findings from Research

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

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. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

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]

In a study of 579 adults with obesity, tirzepatide significantly enhanced weight loss after a 12-week lifestyle intervention, achieving an average additional weight reduction of 18.4% compared to just 2.5% with placebo over 72 weeks.

The treatment was well-tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating that tirzepatide is a safe and effective option for further weight management in individuals who have already lost weight through lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Wadden, TA., Chao, AM., Machineni, S., et al.[2023]

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]

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., et al.[2023]

In a 72-week phase 3 trial involving 2539 adults with obesity, tirzepatide (5 mg, 10 mg, or 15 mg) resulted in significant weight loss, with mean reductions of -15.0%, -19.5%, and -20.9% respectively, compared to only -3.1% with placebo.

A high percentage of participants (85% to 91%) on tirzepatide achieved at least a 5% weight reduction, and many experienced improvements in cardiometabolic measures, although gastrointestinal side effects were the most common adverse events, mostly mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. Jastreboff, AM., Aronne, LJ., Ahmad, NN., et al.[2023]

Tirzepatide, a novel GLP-1 receptor agonist, has been shown to significantly reduce A1C levels and body weight in patients with type 2 diabetes compared to placebo and other active treatments.

The safety profile of tirzepatide is similar to other GLP-1 receptor agonists, with the most common side effects being mild to moderate gastrointestinal issues, and it does not increase the risk of hypoglycemia, making it a promising treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. Kushner, P., Anderson, JE., Simon, J., et al.[2023]

Tirzepatide, a dual-action drug for type 2 diabetes, has shown significant improvements in glycemic control and weight loss (between -6.2 to -12.9 kg) in phase 3 clinical trials, making it more effective than other diabetes medications.

The drug is well tolerated with a low risk of hypoglycemia and has demonstrated cardiovascular benefits, including improved lipid profiles and reduced blood pressure, with ongoing studies expected to provide further insights into its safety and potential uses in obesity and heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A Promising Drug for Type 2 Diabetes and Beyond. Dutta, P., Kumar, Y., Babu, AT., et al.[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]