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

Last updated: October 15, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

LY3537031

Placebo

Clinical Study ID

NCT06606106
27199
J2S-MC-GZMD
  • Ages 22-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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 48 weeks excluding a screening period.

Eligibility Criteria

Inclusion

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 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 laboratoryranges.

Exclusion

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 35nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL), 10.2 picomoles perliter (pmol/L))

Study Design

Total Participants: 302
Treatment Group(s): 2
Primary Treatment: LY3537031
Phase: 1
Study Start date:
September 05, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • PRIM: Fortrea CRU, Inc

    Daytona Beach, Florida 32117
    United States

    Active - Recruiting

  • Clinical Pharmacology of Miami

    Miami, Florida 33172
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Daytona Beach 4152872, Florida 4155751 32117
    United States

    Site Not Available

  • Clinical Pharmacology of Miami

    Miami 4164138, Florida 4155751 33172
    United States

    Site Not Available

  • QPS

    Springfield, Missouri 65802
    United States

    Site Not Available

  • QPS

    Springfield 4409896, Missouri 4398678 65802
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Dallas, Texas 75247
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Dallas 4684888, Texas 4736286 75247
    United States

    Site Not Available

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