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Completed

NCT Number: NCT06557356

A Study of LY3532226 in Participants With Obesity

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology, Singapore

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3532226

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 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

  3. 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

    Time frame: Baseline to Study Completion (Up to 8 Weeks)]

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

Secondary outcomes

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

    Time frame: Predose on Day 1 through Week 16

    PK: Cmax of LY3532226

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

    Time frame: Predose on Day 1 through Week 16

    PK: AUC of LY3532226

  3. Part B: PK: Cmax of LY3532226

    Time frame: Predose on Day 1 through Week 20

    PK: Cmax of LY3532226

  4. Part B: PK: AUC of LY3532226

    Time frame: Predose on Day 1 through Week 20

    PK: AUC of LY3532226

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

    Time frame: Baseline up to Approximately Week 4

    Part C: PD: Change in Si

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Dose-Escalation Phase 1, Investigator- and Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3532226 in Participants With Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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