1217 Participants Needed

LY3305677 for Obesity

Recruiting at 65 trial locations
RC
DT
AF
WS
EJ
Jeffrey A Norton profile photo
Awawu Igbinadolor profile photo
Jeffrey A Norton profile photo
Overseen ByJeffrey A Norton
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.25678

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.145910

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • LY900038
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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: LY3841136 Obesity ISA LAA2Experimental Treatment3 Interventions
Group II: LY3841136 Obesity ISA LAA1Experimental Treatment2 Interventions
Group III: LY3549492 Obesity ISA GN02Experimental Treatment2 Interventions
Group IV: LY3549492 Obesity ISA GN01Experimental Treatment2 Interventions
Group V: LY3305677 Obesity ISA OXA1Experimental Treatment2 Interventions

LY900038 is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Wegovy for:
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Approved in United States as Ozempic for:
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Approved in United States as Rybelsus for:
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Approved in European Union as Semaglutide for:
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Approved in Canada as Semaglutide for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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 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.
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 glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.
In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.
Semaglutide for the treatment of obesity.Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]
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.
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer?Colin, IM., Gérard, KM.[2022]

Citations

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. [2021]
Semaglutide for the treatment of obesity. [2023]
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]
Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity. [2022]
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]
Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. [2023]
High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]
Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]
Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis. [2023]
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]
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