LY3841136 + Tirzepatide for Obesity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments to determine their safety and tolerance in individuals who are overweight or obese. Participants will take a new drug, LY3841136, alongside tirzepatide. Some will receive a placebo (a harmless, inactive substance) with tirzepatide for comparison. Individuals with a stable weight, who are generally healthy, and have a Body Mass Index (BMI) between 27 and 45 may be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that tirzepatide is usually well-tolerated. In earlier studies, most side effects were mild to moderate, such as stomach issues like nausea, while serious side effects were less common.

For LY3841136, less information is available because it remains in early testing. The trial is in its first phase, focusing on safety, determining the right dose, and monitoring for problems. Although data is limited, reaching this stage suggests initial safety checks have shown some promise.

Overall, the combination of LY3841136 and tirzepatide aims to be safe. However, researchers are carefully monitoring for any issues as testing continues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about LY3841136 combined with tirzepatide for obesity because it offers a new approach compared to existing treatments like lifestyle modifications, orlistat, and bariatric surgery. Unlike these options, LY3841136 is a subcutaneous drug that may work synergistically with tirzepatide to enhance weight loss. This combination could potentially target metabolic pathways more effectively, offering an innovative strategy to tackle obesity with potentially improved outcomes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that tirzepatide helps people with obesity lose weight. In one study, participants taking tirzepatide lost significant weight and maintained it, making it a promising option for weight management. This trial examines two treatment arms: one where participants receive LY3841136 with tirzepatide, and another where they receive a placebo with tirzepatide. While information on LY3841136 remains limited, the combination aims to enhance weight loss results. Early findings suggest potential benefits, but further research is necessary for confirmation. ^{2 3 4 5 6}

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?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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, 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, 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06603571

NCT06603571 | A Study to Investigate Weight ... A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight ...

2. trials.lilly.com trials.lilly.com/en-US/trial/533180

A Study to Investigate Weight Management With ... - Lilly Trials To investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06345066

A Study of LY3841136 in Overweight and Obese Participants 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 ...

4. 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 ...

5. withpower.com withpower.com/trial/ly3841136-tirzepatide-for-obesity-c20b7

LY3841136 + Tirzepatide for Obesity · Info for Participants Tirzepatide, administered once weekly, has been shown to be effective in promoting weight loss in individuals with obesity, as demonstrated in a clinical study.

6. trials.lilly.com trials.lilly.com/en-US/trial/471555

A Study of LY3841136 in Overweight and Obese Participants The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatitide in overweight and ...