LY3841136 for Obesity

Recruiting at 56 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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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 is safe and effective over several months.

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.

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

The available research shows that LY3437943, which is similar to LY3841136, has been effective in reducing body weight in obese mice and has shown promising results in early human trials. In a study, a single dose of LY3437943 led to a reduction in body weight that lasted up to 43 days. This suggests that LY3841136 might also be effective for weight loss in humans. However, more research is needed to confirm its effectiveness compared to other treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the drug LY3841136 for obesity?

Research on a similar drug, LY3437943, which targets the same receptors, showed that it helped reduce body weight and improve blood sugar control in obese mice and had a lasting weight loss effect in humans after a single dose. This suggests that LY3841136 might also be effective for weight loss. ^{1 2 3 4 5}

What safety data exists for LY3841136 for obesity treatment?

The provided research does not mention LY3841136 specifically. However, it discusses the safety of liraglutide, a GLP-1 receptor agonist used for obesity management. Liraglutide has been associated with adverse events such as nausea, vomiting, dizziness, headache, cardiovascular issues, and kidney complications. The FAERS database analysis highlights serious adverse events, including cardiovascular and kidney complications, associated with anti-obesity medications like liraglutide. Continuous monitoring of these medications is necessary to ensure patient safety. ^{6 7 8 9 10}

What safety data exists for LY3841136 in humans?

The safety of anti-obesity medications, including those similar to LY3841136, has been associated with serious side effects like nausea, vomiting, dizziness, headaches, and cardiovascular and kidney complications. It's important to monitor these medications closely to ensure patient safety. ^{6 7 8 9 10}

Is the drug LY3841136 a promising treatment for obesity?

The information provided does not directly mention LY3841136, so we cannot determine if it is a promising treatment for obesity based on the given articles. ^{7 9 11 12 13}

How does the drug LY3841136 differ from other obesity treatments?

LY3841136 is unique because it may involve a novel mechanism or combination not covered by existing treatments like liraglutide, which is a GLP-1 receptor agonist used for weight loss. While specific details about LY3841136 are not provided, it could potentially offer a new approach compared to current options such as combination therapies or other GLP-1 based treatments. ^{7 9 11 12 13}

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 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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States 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. [2022]

3. England 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. [2022]

4. England 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. [2019]

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

Rapid Evidence Review of Bariatric Surgery in Super Obesity (BMI ≥ 50 kg/m2). [2020]

6. Netherlands 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. [2022]

7. England 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. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Current pharmacotherapy for obesity. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. [2022]

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

Horizons in the Pharmacotherapy of Obesity. [2018]

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

Combination Therapies for Obesity. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. [2022]