LY3841136 for Obesity

No longer recruiting at 7 trial locations

Overseen By Nicholas Siebers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Heart, Liver, Kidney, others

Compensation: Varies

Number of Visits: 26

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new treatment called LY3841136 for obesity. Researchers aim to understand how the drug behaves in the body, including its absorption into the bloodstream and its duration there. The trial consists of two parts with varying dose levels and placebo comparisons. Individuals with a stable weight for the past three months and a BMI between 18.5 and 40 may qualify, depending on the trial part. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have diabetes or chronic conditions involving the heart, liver, or kidneys, you may not be eligible to participate.

Is there any evidence suggesting that LY3841136 is likely to be safe for humans?

Research has shown that LY3841136 is being tested for safety and tolerability. In earlier studies, healthy and overweight individuals received this medication. These studies found that the treatment was generally well-tolerated. Some participants experienced mild side effects, mostly related to the stomach, such as nausea or an upset stomach. These side effects were usually temporary and not serious.

LY3841136 is a new drug called an amylin receptor agonist, which targets specific body parts to help control weight. While more research is ongoing, these early results suggest that most people can take LY3841136 without major problems. However, since this is an early trial phase, gathering more information about its safety remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LY3841136 is unique because, unlike many current treatments for obesity that focus on appetite suppression or increased metabolism, it is administered subcutaneously with both single and multiple ascending doses, potentially offering a more tailored approach to dosing. Researchers are excited about this treatment because it introduces a new method of delivery that might provide more consistent and controlled results. Additionally, the potential for scalable dosing could mean more personalized treatment options for patients, making it an exciting development in obesity management.

What evidence suggests that LY3841136 might be an effective treatment for obesity?

Research shows that LY3841136 is a new medication that acts like a hormone to help control appetite. It might help people feel full faster and eat less, potentially leading to weight loss. In this trial, participants will receive either LY3841136 or a placebo. Early results suggest that taking LY3841136 once a week could effectively treat obesity due to its positive effects. Although human studies have provided limited data so far, initial signs are encouraging for weight management. More detailed studies are needed to confirm these effects. ^{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?

This trial is for healthy or overweight males and non-childbearing potential females with a stable weight. Participants must have a BMI of 18.5-32 kg/m² (Part A) or 27-40 kg/m² (Part B). They should agree to use contraception. Those with diabetes, lactating women, allergies to LY3841136 components, significant heart/liver/kidney diseases, severe allergies, or drug hypersensitivity cannot join.

Inclusion Criteria

Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Have had a stable weight for the last 3 months

Exclusion Criteria

Have been diagnosed with Type 1 or Type 2 diabetes mellitus

Are women who are lactating

Have known allergies to related compounds of LY3841136 or any components of the formulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive single ascending doses of LY3841136 or placebo administered subcutaneously

14 weeks

7 visits

Treatment Part B

Participants receive multiple ascending doses of LY3841136 or placebo administered subcutaneously

28 weeks

19 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3841136
• Placebo

Trial Overview

The study tests the safety and how the body processes LY3841136 in two parts over up to 14 weeks (Part A) and up to 28 weeks (Part B), involving multiple visits. It compares LY3841136 against a placebo in healthy and overweight individuals through blood tests.

How Is the Trial Designed?

Group I: LY3841136 (Part B) Experimental Treatment 1 Intervention

Multiple ascending doses of LY3841136 administered SC.

Group II: LY3841136 (Part A) Experimental Treatment 1 Intervention

Single ascending doses of LY3841136 administered subcutaneously (SC).

Group III: Placebo (Part A) Placebo Group 1 Intervention

Placebo administered SC.

Group IV: Placebo (Part B) Placebo Group 1 Intervention

Placebo administered 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

In a 16-week study involving 140 overweight adults, the herbal extract LI85008F led to significant weight loss (5.36 kg) and reductions in BMI compared to a placebo group, indicating its efficacy for weight management.

Participants taking LI85008F also experienced improvements in their lipid profiles, with decreased LDL cholesterol and increased HDL cholesterol, and no major adverse events were reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. Dixit, K., Kamath, DV., Alluri, KV., et al.[2019]

In a 12-week study involving 72 adults with type 2 diabetes, the multi-receptor agonist LY3437943 demonstrated a good safety profile, with gastrointestinal disorders being the most common side effects.

LY3437943 significantly reduced daily plasma glucose and HbA1c levels, as well as body weight, in a dose-dependent manner, supporting its potential for once-weekly dosing and further development in treating type 2 diabetes and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Urva, S., Coskun, T., Loh, MT., et al.[2022]

Bariatric surgery in patients with a BMI ≥ 50 kg/m2 shows mixed outcomes; while it may increase short-term mortality, it appears to decrease long-term mortality among super obese veterans, based on a review of 23 studies.

Different surgical methods yield varying results: laparoscopic gastric bypass offers better short-term weight loss, while duodenal switch provides greater long-term weight loss but with higher complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Evidence Review of Bariatric Surgery in Super Obesity (BMI ≥ 50 kg/m2). Peterson, K., Anderson, J., Boundy, E., et al.[2020]

In a phase 2 study involving 316 participants with poorly controlled type 2 diabetes, the dual receptor agonist LY3298176 demonstrated significantly better glucose control and weight loss compared to dulaglutide, with a dose-dependent reduction in HbA1c levels.

LY3298176 was generally well-tolerated, with gastrointestinal side effects being the most common but mostly mild to moderate, indicating a favorable safety profile for this new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Frias, JP., Nauck, MA., Van, J., et al.[2022]

In a study of 217 individuals undergoing bariatric surgery, women with the rs17782313 polymorphism near the MC4R gene had higher pre-surgical body weight and BMI compared to non-carriers, indicating a potential genetic influence on obesity severity.

Carriers of the rs17782313 polymorphism were less likely to achieve significant weight loss success post-surgery, with only 17% reaching a BMI below 30 kg/m² after 24 months, compared to 37% of non-carriers, suggesting that this genetic variant may be associated with poorer long-term outcomes after bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The polymorphism rs17782313 near MC4R gene is related with anthropometric changes in women submitted to bariatric surgery over 60 months. Resende, CMM., Durso, DF., Borges, KBG., et al.[2019]

Liraglutide, a GLP-1 receptor agonist, is effective for weight loss in overweight or obese patients, showing greater weight reduction compared to placebo and orlistat, particularly at a dosage of 3 mg daily.

In addition to weight loss, liraglutide has been associated with significant health improvements, including reductions in waist circumference, blood pressure, and better lipid profiles, making it a beneficial option for patients with or without type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. Moore, KG., Shealy, K., Clements, JN.[2022]

Combination therapies for obesity treatment, such as pramlintide with phentermine and GLP-1 with glucagon, show promising efficacy beyond traditional diet and lifestyle changes.

Recent trials indicate that combining intragastric balloon treatments with GLP-1 analogs like liraglutide may enhance weight loss outcomes, suggesting a potential new direction for obesity management in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapies for Obesity. Camilleri, M., Acosta, A.[2019]

LY3437943 is a novel triple agonist that targets three receptors related to metabolism, showing promising results in obese mice by reducing body weight and improving blood sugar control.

In a phase 1 study, LY3437943 demonstrated a safety profile similar to existing treatments and supported once-weekly dosing, with weight loss effects lasting up to 43 days after a single dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Coskun, T., Urva, S., Roell, WC., et al.[2022]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

In a 20-week double-blind trial with 564 obese participants, liraglutide led to significantly greater weight loss compared to placebo and orlistat, with mean weight losses ranging from 4.8 kg to 7.2 kg depending on the dose.

Liraglutide not only promoted weight loss but also improved obesity-related health factors, such as reducing blood pressure and the prevalence of prediabetes, while being generally well tolerated despite some transient nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Astrup, A., Rössner, S., Van Gaal, L., et al.[2022]

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LY3841136 for Obesity · Info for Participants

In a 16-week study involving 140 overweight adults, the herbal extract LI85008F led to significant weight loss (5.36 kg) and reductions in BMI compared to a ...

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withpower.com

withpower.com/trial/phase-2-overweight-1-2024-40dd6

LY3841136 for Obesity · Info for Participants

This trial is testing a new medication called LY3841136 to help adults who are overweight or obese manage their weight. The study aims to see if this medication ...

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A Study of LY3841136 in Healthy and Overweight ...

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