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

Phase 1Active Not RecruitingNCT06606106

Eli Lilly and Company302 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

302

Conditions

Overweight Obesity

Interventions

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. 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), 10.2 picomoles per liter (pmol/L))

Locations (5)

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

QPS

Springfield, Missouri, United States

Fortrea Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline to Study Completion (Up to 56 Weeks)

Secondary Outcomes

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

Time frame: Predose on Day 1 through Week 56

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

Time frame: Predose on Day 1 through Week 56

Pharmacodynamic (PD): Change from Baseline in Body Weight

Time frame: Baseline up to Week 56

PD: Change from Baseline in Fasting Glucose

Time frame: Baseline up to Week 56

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

Time frame: Baseline up to Week 56

PD: Change from Baseline in AUC of Glucose