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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3537031 Part A (Cohorts 1-7)

Multiple-ascending doses of LY3537031 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY3537031

Intervention Type DRUG

Administered SC

Placebo Part A

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

LY3537031 Part B (Cohorts 8-11)

Multiple-ascending doses of LY3537031 administered SC

Group Type EXPERIMENTAL

LY3537031

Intervention Type DRUG

Administered SC

Placebo Part B

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

LY3537031 Part C (Cohorts 12-15)

Multiple-ascending doses of LY3537031 administered SC

Group Type EXPERIMENTAL

LY3537031

Intervention Type DRUG

Administered SC

Placebo Part C

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

LY3537031 Part D (Cohorts 16-19)

Multiple-ascending doses of LY3537031 administered SC

Group Type EXPERIMENTAL

LY3537031

Intervention Type DRUG

Administered SC

Placebo Part D

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3537031

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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))

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes