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

NCT06606106 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27199J2S-MC-GZMD
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 5

Brief Summary

This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D 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 49 weeks excluding a screening period.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline to Study Completion (Up to 56 Weeks)

Secondary Outcomes (11)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031

  Predose on Day 1 through Week 56

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031

  Predose on Day 1 through Week 56

• Pharmacodynamic (PD): Change from Baseline in Body Weight

  Baseline up to Week 56

• PD: Change from Baseline in Fasting Glucose

  Baseline up to Week 56

• PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results

  Baseline up to Week 56

Study Arms (8)

LY3537031 Part A (Cohorts 1-7)

EXPERIMENTAL

Multiple-ascending doses of LY3537031 administered subcutaneously (SC)

Drug: LY3537031

Placebo Part A

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3537031 Part B (Cohorts 8-11)

EXPERIMENTAL

Multiple-ascending doses of LY3537031 administered SC

Drug: LY3537031

Placebo Part B

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3537031 Part C (Cohorts 12-15)

EXPERIMENTAL

Multiple-ascending doses of LY3537031 administered SC

Drug: LY3537031

Placebo Part C

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3537031 Part D (Cohorts 16-19)

EXPERIMENTAL

Multiple-ascending doses of LY3537031 administered SC

Drug: LY3537031

Placebo Part D

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3537031 DRUG

Administered SC

LY3537031 Part A (Cohorts 1-7); LY3537031 Part B (Cohorts 8-11); LY3537031 Part C (Cohorts 12-15); LY3537031 Part D (Cohorts 16-19)

Placebo DRUG

Administered SC

Placebo Part A; Placebo Part B; Placebo Part C; Placebo Part D

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a BMI within the range of:
• Parts A and D: 27.0 to 45.0 kilogram per square meter (kg/m²)
• Parts B and C: 22.0 to 26.9 kg/m²
• Parts B and C: Weigh 60 kg (80 pounds (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.

You may not qualify if:

• 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), 10.2 picomoles per liter (pmol/L))

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

Location

QPS

Springfield, Missouri, 65802, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Related Links

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

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 20, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)