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LY3305677 for Obesity
Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a BMI ≥27 kg/m²and <30 kg/m² with at least one weight-related comorbidity such as hypertension on blood pressure (BP)-lowering medication, dyslipidemia on lipid-lowering medication, cardiovascular (CV) disease, or obstructive sleep apnea
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Summary
This trial creates a framework to evaluate the safety and efficacy of weight management interventions. Different interventions can be tested independently.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects aren't listed here but typically include reactions at the injection site, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue and potentially allergic reactions to components of the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 27 and 30, and I have a weight-related health issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Allocated to Each ISA
Trial Design
4Treatment groups
Experimental Treatment
Group I: LY3841136 Obesity ISA LAA2Experimental Treatment3 Interventions
Participants will receive LY3841136, tirzepatide and placebo SC.
Each ISA will detail the intervention specific analysis.
Group II: LY3841136 Obesity ISA LAA1Experimental Treatment2 Interventions
Participants will receive LY3841136 or placebo SC.
Each ISA will detail the intervention specific analysis.
Group III: LY3549492 Obesity ISA GN01Experimental Treatment2 Interventions
Participants will receive LY3549492 orally.
Each ISA will detail the intervention specific analysis.
Group IV: LY3305677 Obesity ISA OXA1Experimental Treatment2 Interventions
Participants will receive LY3305677 or placebo subcutaneously (SC).
Each ISA will detail the intervention specific analysis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3841136
2022
Completed Phase 1
~150
LY3549492
2021
Completed Phase 1
~160
Tirzepatide
2019
Completed Phase 3
~7520
LY3305677
2017
Completed Phase 1
~180
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,465,344 Total Patients Enrolled
69 Trials studying Obesity
46,047 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company