LY3537031 for Obesity

Recruiting at 5 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Bariatric surgery, Lactating, High calcitonin, others

Compensation: Varies

Number of Visits: Unknown

230 Participants Needed

Trial Summary

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.

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 48 weeks excluding a screening period.

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.

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.

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

Trial Overview The 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

Group I: LY3537031 Part C (Cohorts 12-15) Experimental Treatment 1 Intervention

Multiple-ascending doses of LY3537031 administered SC

Group II: LY3537031 Part B (Cohorts 8-11) Experimental Treatment 1 Intervention

Multiple-ascending doses of LY3537031 administered SC

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

Multiple-ascending doses of LY3537031 administered subcutaneously (SC)

Group IV: Placebo Part A Placebo Group 1 Intervention

Placebo administered SC

Group V: Placebo Part B Placebo Group 1 Intervention

Placebo administered SC

Group VI: Placebo Part C Placebo Group 1 Intervention

Placebo administered SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University