A Study of LY3532226 in Participants With Obesity

NCT06557356 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18835J2V-MC-GZLD
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 4

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. Part C of the study will last approximately 8 weeks, excluding the screening period.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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

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

  Baseline to Study Completion (Up to 16 Weeks)

• 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

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

  Baseline to Study Completion (Up to 20 Weeks)

• Part C: 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

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

  Baseline to Study Completion (Up to 8 Weeks)]

Secondary Outcomes (5)

• Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226

  Predose on Day 1 through Week 16

• Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226

  Predose on Day 1 through Week 16

• Part B: PK: Cmax of LY3532226

  Predose on Day 1 through Week 20

• Part B: PK: AUC of LY3532226

  Predose on Day 1 through Week 20

• Part C: Pharmacodynamic (PD): Change in insulin sensitivity index (Si)

  Baseline up to Approximately Week 4

Study Arms (6)

LY3532226 (Part A)

EXPERIMENTAL

LY3532226 administered subcutaneously (SC)

Drug: LY3532226

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3532226 (Part B)

EXPERIMENTAL

LY3532226 administered SC

Drug: LY3532226

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3532226 (Part C)

EXPERIMENTAL

LY3532226 administered SC

Drug: LY3532226

Placebo (Part C)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3532226 DRUG

Administered SC

LY3532226 (Part A); LY3532226 (Part B); LY3532226 (Part C)

Placebo DRUG

Administered SC

Placebo (Part A); Placebo (Part B); Placebo (Part C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Links

• Lilly Trials

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; 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 9 AM - 5 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 14, 2024
• First Posted: August 16, 2024
• Study Start: August 16, 2024
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (3)