A Study of LY3532226 in Participants With Obesity

Phase 1

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: LY3532226

• Registration Number: NCT06557356
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study Start: 2024-08-16
• Study First Posted: 2024-08-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
• Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment

Exclusion Criteria

• Have a lifetime history of a suicide attempt
• Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
• Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
• Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
• Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
• Intend to use any weight-loss medications during study participation
• Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Part B)	Placebo	Placebo administered SC
LY3532226 (Part A)	LY3532226	LY3532226 administered subcutaneously (SC)
Placebo (Part A)	Placebo	Placebo administered SC
LY3532226 (Part B)	LY3532226	LY3532226 administered SC

Primary Outcome Measures

Name	Time	Method
Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline to Study Completion (Up to 16 Weeks)	A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part B: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline to Study Completion (Up to 20 Weeks)	A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Part B: PK: AUC of LY3532226	Predose on Day 1 through Week 20	PK: AUC of LY3532226
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226	Predose on Day 1 through Week 16	PK: Cmax of LY3532226
Part B: PK: Cmax of LY3532226	Predose on Day 1 through Week 20	PK: Cmax of LY3532226
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226	Predose on Day 1 through Week 16	PK: AUC of LY3532226

Trial Locations

Locations (2)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore