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NCT Number: NCT06606106

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Research, LLC, Los Alamitos, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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))

Treatment and study plan

LY3537031

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

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

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

Secondary outcomes

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

    Time frame: Predose on Day 1 through Week 56

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

    Time frame: Predose on Day 1 through Week 56

  3. Pharmacodynamic (PD): Change from Baseline in Body Weight

    Time frame: Baseline up to Week 56

  4. PD: Change from Baseline in Fasting Glucose

    Time frame: Baseline up to Week 56

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

    Time frame: Baseline up to Week 56

  6. PD: Change from Baseline in AUC of Glucose

    Time frame: Baseline Up to Week 56

  7. PD: Change from Baseline in Insulin Levels

    Time frame: Baseline Up to Week 56

  8. PD: Change from Baseline in Connecting Peptide (C-peptide) Levels

    Time frame: Baseline Up to Week 56

  9. PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying

    Time frame: Baseline up to Week 56

  10. PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying

    Time frame: Baseline Up to Week 56

  11. PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying

    Time frame: Baseline Up to Week 56

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 20, 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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