A Study of LY3532226 in Participants With Obesity

NCT06557356
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Phase
Phase 1
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Recruitment status
Completed
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Participants
132
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Lead sponsor
Eli Lilly and Company
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Start date
2024-08-16
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Number of sites
4
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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.
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Short title
A Study of LY3532226 in Participants With Obesity
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-12-12
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First posted
2024-08-16
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Registry last updated
2026-01-20
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Primary completion date
2025-12-12
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Start date
2024-08-16
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Actual participants
132
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Participants
132
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06557356
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ClinicalTrials.gov ID
NCT06557356
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

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

    Timeframe: 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

    Timeframe: Predose on Day 1 through Week 16

    PK: AUC of LY3532226

  3. Part B: PK: Cmax of LY3532226

    Timeframe: Predose on Day 1 through Week 20

    PK: Cmax of LY3532226

  4. Part B: PK: AUC of LY3532226

    Timeframe: Predose on Day 1 through Week 20

    PK: AUC of LY3532226

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

    Timeframe: Baseline up to Approximately Week 4

    Part C: PD: Change in Si

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • Fortrea Clinical Research UnitDaytona Beach, United States
  • Fortrea Clinical Research UnitDallas, United States
  • Fortrea Clinical Research UnitMadison, United States
  • Lilly Centre for Clinical PharmacologySingapore, Singapore
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2V-MC-GZLD
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)