LY3305677 for Obesity

Recruiting in Palo Alto (17 mi)

+64 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Type 1 diabetes, Hypertension, Liver disease, others

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

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 effectiveness of the drug LY3305677 for obesity?

Research shows that semaglutide, a component of LY3305677, is effective for weight loss, with studies indicating it can lead to a 15% reduction in body weight over 68 weeks. It is considered a 'game changer' in obesity treatment, providing significant and sustained weight loss compared to other available medications. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide has been studied for its safety in treating obesity, and it is generally considered safe for humans. It has been approved by the US Food and Drug Administration for chronic weight management, with studies showing improvements in weight loss and cardiovascular risk factors. ^{1 2 5 6 7}

How is the drug LY900038 (Semaglutide) unique for treating obesity?

Semaglutide is unique for treating obesity because it is a once-weekly injection that helps reduce appetite and energy intake, leading to weight loss. It also improves cardiometabolic risk factors, which are important for heart health, in people with obesity. ^{1 6 8 9 10}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4550 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 with obesity, defined as having a BMI ≥30 kg/m², or overweight individuals (BMI ≥27 kg/m² and <30 kg/m²) with weight-related health issues like high blood pressure on medication, cholesterol problems on drugs, heart disease, or sleep apnea. Participants should have maintained their body weight within a 5% range in the past 3 months.

Inclusion Criteria

Your body weight has not changed by more than 5% in the past 3 months before joining the study.

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

You have a BMI of 30 or higher.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various investigational interventions for chronic weight management as per the intervention-specific appendices (ISAs)

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• LY900038 (Other)

Trial Overview The study is testing the safety and effectiveness of various potential treatments for chronic weight management. One group will receive an investigational drug called LY3305677 while another group will get a placebo. The interventions are part of separate appendices that can start at different times.

Participant Groups

Group I: LY3841136 Obesity ISA LAA2 Experimental Treatment 3 Interventions

Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.

Group II: LY3841136 Obesity ISA LAA1 Experimental Treatment 2 Interventions

Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.

Group III: LY3549492 Obesity ISA GN01 Experimental Treatment 2 Interventions

Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.

Group IV: LY3305677 Obesity ISA OXA1 Experimental Treatment 2 Interventions

Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.

LY900038 is already approved in Canada for the following indications:

Approved in Canada as Semaglutide for:

• Type 2 diabetes mellitus
• Chronic weight management in adults with obesity or overweight with at least one weight-related condition

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 20-week trial with 72 adults, once-weekly subcutaneous semaglutide 2.4 mg significantly reduced appetite and energy intake, leading to a 9.9% reduction in body weight compared to only 0.4% with placebo.

Semaglutide improved participants' control over eating and reduced food cravings without causing delayed gastric emptying, indicating its efficacy in managing obesity without adverse effects on gastric function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Friedrichsen, M., Breitschaft, A., Tadayon, S., et al.[2021]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

Obesity is a major public health concern, with projections indicating that over 1.1 billion individuals will be affected by 2030, highlighting the urgent need for effective treatments.

GLP-1 receptor agonists, particularly semaglutide, are at the forefront of clinical development for obesity treatment, showing promise in improving metabolic health and potentially serving as a benchmark for future anti-obesity therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity. Jepsen, MM., Christensen, MB.[2022]

High-dose once-weekly semaglutide has been shown to significantly reduce weight in patients with obesity or overweight, as demonstrated in four phase 3 clinical trials involving various populations, including those with diabetes.

While gastrointestinal side effects were common, semaglutide was generally well tolerated and also led to improvements in cardiometabolic risk factors, such as waist circumference and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2022]

Semaglutide, approved by the FDA on June 4, 2021, is the first new drug for chronic weight management in adults with obesity or overweight since 2014, specifically targeting those with a BMI of 27 or greater and at least one weight-related condition.

This medication is intended to be used alongside a weight management program that includes a reduced-calorie diet and increased physical activity, highlighting its role as part of a comprehensive approach to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Mares, AC., Chatterjee, S., Mukherjee, D.[2023]

Semaglutide 2.4 mg led to significant weight loss in adults with overweight/obesity, achieving a mean change of -15.7% for those on antidepressants compared to -0.2% for placebo, demonstrating its efficacy regardless of antidepressant use.

The safety profile of semaglutide was consistent with previous studies, showing a similar prevalence of adverse events between the semaglutide and placebo groups among participants taking antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis. Kushner, RF., Fink-Jensen, A., Frenkel, O., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. [2021]

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

Semaglutide for the treatment of obesity. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. [2023]

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

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]

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

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]

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

Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis. [2023]

10. 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]