A Study of LY3537031 in Overweight, Obese, and Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy; Obesity
• Interventions: Drug: LY3537031; Drug: Placebo

• Registration Number: NCT06606106
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This is a 3-part study that includes a Part A, Part B, and Part C. Part A will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants.

Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 48 weeks excluding a screening period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study Start: 2024-09-05
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Have a BMI within the range of:

  • Part A: 27.0 to 45.0 kilogram per square meter (kg/m²)
  • Part B: 22.0 to 26.9 kg/m²

• Parts B and C: Weigh 60 kg (80 lbs) or more at screening

• Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening

• Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.

Exclusion Criteria

• Have undergone any form of bariatric surgery
• Participants who are lactating
• Have taken medications that promote weight loss within 90 days before screening
• Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537031 Part A (Cohorts 1-7)	LY3537031	Multiple-ascending doses of LY3537031 administered subcutaneously (SC)
Placebo Part A	Placebo	Placebo administered SC
LY3537031 Part B (Cohorts 8-11)	LY3537031	Multiple-ascending doses of LY3537031 administered SC
Placebo Part B	Placebo	Placebo administered SC
LY3537031 Part C (Cohorts 12-15)	LY3537031	Multiple-ascending doses of LY3537031 administered SC
Placebo Part C	Placebo	Placebo administered SC

Primary Outcome Measures

Name	Time	Method
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	Baseline to Study Completion (Up to 56 Weeks)	A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031	Predose on Day 1 through Week 56	PK: Cmax of LY3537031
PD: Change from Baseline in AUC of Glucose	Baseline Up to Week 56	PD: Change from Baseline in AUC of Glucose
PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying	Baseline Up to Week 56	PD: Change from Baseline in Tmax of Acetaminophen to Assess the Delay in Gastric Emptying
PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying	Baseline up to Week 56	PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying
PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying	Baseline Up to Week 56	PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031	Predose on Day 1 through Week 56	PK: AUC of LY3537031
Pharmacodynamic (PD): Change from Baseline in Body Weight	Baseline up to Week 56	PD: Change from Baseline in Body Weight
PD: Change from Baseline in Fasting Glucose	Baseline up to Week 56	PD: Change from Baseline in Fasting Glucose
PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results	Baseline up to Week 56	PD: Change from Baseline in OGTT Results
PD: Change from Baseline in Insulin Levels	Baseline Up to Week 56	PD: Change from Baseline in Insulin Levels
PD: Change from Baseline in Connecting Peptide (C-peptide) Levels	Baseline Up to Week 56	PD: Change from Baseline in Connecting Peptide (C-peptide) Levels

Trial Locations

Locations (4)

Collaborative Neuroscience Research, LLC; 🇺🇸 Los Alamitos, California, United States

Fortrea Clinical Research Unit; 🇺🇸 Dallas, Texas, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

QPS; 🇺🇸 Springfield, Missouri, United States