LY3841136 for Obesity

No longer recruiting at 59 trial locations

Overseen By Awawu Igbinadolor

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Cardiovascular conditions, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 64 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3841136 to determine its effectiveness and safety in helping people with obesity or those who are overweight manage their weight. Participants will receive varying doses of LY3841136 or a placebo (a substance with no active drug) for comparison. The trial targets adults with a BMI of 27 or higher who have maintained a stable weight for the past three months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss this 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. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that LY3841136 is usually safe for people. In earlier studies, participants taking LY3841136 did not experience serious side effects. One study even found that a single dose helped people lose weight, suggesting its potential as a treatment. However, some weight-loss drugs have been associated with serious issues like heart and kidney problems. While these issues are not specifically linked to LY3841136, they are important to consider. This trial is in an early stage and aims to further assess the treatment's safety. Participants should discuss any concerns with their doctor before joining the trial. ^{1 2 3 4 5}

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

Researchers are excited about LY3841136 for obesity because it offers a new approach compared to current treatments like lifestyle changes, medications such as orlistat, and surgical options like gastric bypass. LY3841136 is administered subcutaneously, which might offer more consistent dosing compared to oral medications. It may target specific pathways in the body that regulate weight, potentially leading to more effective weight loss. This innovative approach could provide a valuable alternative for those who struggle with existing treatments.

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

Research has shown that LY3841136, also known as Eloralintide, holds promise for weight loss. Earlier studies found it safe for humans and effective in promoting weight loss after just one dose. This suggests potential for treating obesity. LY3841136 targets brain areas that control hunger and energy use. The combination of safety and initial weight loss results makes it a hopeful option for weight management. Participants in this trial will receive varying doses of LY3841136 or a placebo to further assess its effectiveness and safety. ^{2 3 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 adults who are overweight or have obesity. Specific details about eligibility criteria were not provided, so interested individuals should consult the study team for more information.

Inclusion Criteria

BMI ≥30 kilograms per square meter (kg/m²)

I agree to follow the study's rules about birth control and pregnancy.

My BMI is between 27 and 30, and I have a weight-related health issue.

Exclusion Criteria

I have liver disease symptoms not caused by fatty liver.

I have attempted suicide in the past.

I have been diagnosed with diabetes, but not just during pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3841136 or placebo subcutaneously for weight management

64 weeks

Up to 17 visits

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 study is testing a new medication called LY3841136 against a placebo to see if it helps with weight management in obese or overweight adults. The trial will go on for about 64 weeks and may require participants to attend up to 13 visits.

How Is the Trial Designed?

Group I: LY3841136 Dose 6 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC

Group II: LY3841136 Dose 5 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC

Group III: LY3841136 Dose 4 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC.

Group IV: LY3841136 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC

Group V: LY3841136 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC

Group VI: LY3841136 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY3841136 subcutaneously (SC)

Group VII: Placebo Placebo Group 1 Intervention

Participants will receive LY3841136 matching placebo

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 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]

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]

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]

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]

Liraglutide, a diabetes medication, has gained approval in both the US and Europe for obesity treatment and is expected to be widely accepted due to its efficacy.

New research is focusing on activating brown adipose tissue to enhance thermogenesis and developing drugs that mimic gut hormones to achieve results similar to bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Horizons in the Pharmacotherapy of Obesity. Arch, JR.[2018]

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]

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]

Over one-third of adults in the USA are affected by obesity, which significantly contributes to serious health issues like diabetes and cardiovascular disease, highlighting the need for more aggressive treatment options beyond lifestyle changes.

The review discusses FDA-approved anti-obesity medications, emphasizing their safety and efficacy, and suggests that future research may focus on personalized medicine to improve individual responses to these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current pharmacotherapy for obesity. Srivastava, G., Apovian, CM.[2022]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

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]

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]

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]

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/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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212877825001784

Eloralintide (LY3841136), a novel amylin receptor agonist ... Eloralintide is well tolerated in humans and reduces weight after a single dose. •. Eloralintide may offer a new and effective therapeutic ...

4. withpower.com withpower.com/trial/phase-1-obesity-2-2022-ee167

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06230523

NCT06230523 | A Study of LY3841136 Compared With ... ... efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05295940

A Study of LY3841136 in Healthy and Overweight ... The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06345066

A Study of LY3841136 in Overweight and Obese Participants Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

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

LY3841136 for Obesity · Info for Participants The FAERS database analysis highlights serious adverse events, including cardiovascular and kidney complications, associated with anti-obesity medications like ...