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LY3537031 for Obesity
Phase 1
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
Weigh 60 kg (80 lbs) or more at screening for Parts B and C
Be older than 18 years old
Must not have
Have undergone any form of bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 through week 20
Summary
"This trial will test a new drug called LY3537031 in overweight/obese individuals in Part A and healthy individuals in Parts B and C. Part C will specifically focus on Japanese and Chinese participants
Who is the study for?
This clinical trial is for overweight or obese individuals, as well as healthy participants including specifically Japanese and Chinese individuals in one part of the study. The main goal is to test the safety and tolerability of a new drug called LY3537031.
What is being tested?
The trial tests LY3537031 against a placebo (a substance with no therapeutic effect) across three parts: Part A focuses on overweight/obese participants, while Parts B and C focus on healthy subjects, including specific ethnic groups in Part C.
What are the potential side effects?
While not explicitly listed here, common side effects may include reactions at the injection site, gastrointestinal issues, fatigue, headaches, or allergic responses. Specific side effects will be monitored through blood tests and other health checks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 60 kg (132 lbs).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had weight loss surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on day 1 through week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 through week 20
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 with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary study objectives
PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying
PD: Change from Baseline in AUC of Glucose
PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying
+8 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3537031 Part C (Cohorts 12-15)Experimental Treatment1 Intervention
Multiple-ascending doses of LY3537031 administered SC
Group II: LY3537031 Part B (Cohorts 8-11)Experimental Treatment1 Intervention
Multiple-ascending doses of LY3537031 administered SC
Group III: LY3537031 Part A (Cohorts 1-7)Experimental Treatment1 Intervention
Multiple-ascending doses of LY3537031 administered subcutaneously (SC)
Group IV: Placebo Part APlacebo Group1 Intervention
Placebo administered SC
Group V: Placebo Part BPlacebo Group1 Intervention
Placebo administered SC
Group VI: Placebo Part CPlacebo Group1 Intervention
Placebo administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3537031
2020
Completed Phase 1
~40
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,154 Total Patients Enrolled
69 Trials studying Obesity
46,857 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,611 Total Patients Enrolled
52 Trials studying Obesity
25,662 Patients Enrolled for Obesity