Clinical trial

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

Active, not recruiting · Phase 1 · 1 countries · Registry ID NCT06606106

Active, not recruitingPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age22 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight, Obesity

Full registry criteria

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))

Treatments and study arms

LY3537031

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

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 AdministrationBaseline 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

Study locations

5 locations were listed when this page was built. The first 40 are shown.

Fortrea Clinical Research Unit🇺🇸 Dallas, Texas, United States

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Fortrea Clinical Research Unit🇺🇸 Daytona Beach, Florida, United States

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

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Clinical Pharmacology of Miami🇺🇸 Miami, Florida, United States

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QPS🇺🇸 Springfield, Missouri, United States

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