Only 51 spots left

~51 spots leftby Jul 2025

LY3537031 for Obesity

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Bariatric surgery, Lactating, High calcitonin, others

Trial Summary

What is the purpose of this trial?

This is a 3-part study that includes a Part A, Part B, and Part C. Part A 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 20 weeks excluding a screening period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken weight loss medications in the 90 days before screening.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This clinical trial is for overweight or obese individuals, as well as healthy participants including specifically Japanese and Chinese individuals in one part of the study. The main goal is to test the safety and tolerability of a new drug called LY3537031.

Inclusion Criteria

Have a BMI within the range of 27.0 to 45.0 kg/m² for Part A and 22.0 to 26.9 kg/m² for Part B

Have no significant 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.

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Exclusion Criteria

Have a serum calcitonin level (at screening) of greater than or equal to 35 ng/L (35 pg/mL)

Participants who are pregnant or lactating

I have had weight loss surgery.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Multiple-ascending doses of LY3537031 administered subcutaneously to overweight and obese participants

Approximately 20 weeks

Treatment Part B

Multiple-ascending doses of LY3537031 administered subcutaneously to healthy participants

Approximately 20 weeks

Treatment Part C

Multiple-ascending doses of LY3537031 administered subcutaneously to Japanese and Chinese healthy participants

Approximately 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

LY3537031 (Other)

Trial OverviewThe trial tests LY3537031 against a placebo (a substance with no therapeutic effect) across three parts: Part A focuses on overweight/obese participants, while Parts B and C focus on healthy subjects, including specific ethnic groups in Part C.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3537031 Part C (Cohorts 12-15)Experimental Treatment1 Intervention

Multiple-ascending doses of LY3537031 administered SC

Group II: LY3537031 Part B (Cohorts 8-11)Experimental Treatment1 Intervention

Multiple-ascending doses of LY3537031 administered SC

Group III: LY3537031 Part A (Cohorts 1-7)Experimental Treatment1 Intervention

Multiple-ascending doses of LY3537031 administered subcutaneously (SC)

Group IV: Placebo Part APlacebo Group1 Intervention

Placebo administered SC