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

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: LY3537031

Study type: Interventional

Funder types: Industry

Identifiers

NCT06606106

27199

J2S-MC-GZMD (Other Identifier)

Details and patient eligibility

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.

Enrollment: 302 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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))

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

302 participants in 8 patient groups, including a placebo group

LY3537031 Part A (Cohorts 1-7)

Experimental group

Description:

Multiple-ascending doses of LY3537031 administered subcutaneously (SC)

Treatment:

Drug: LY3537031

Placebo Part A

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

LY3537031 Part B (Cohorts 8-11)

Experimental group

Description:

Multiple-ascending doses of LY3537031 administered SC

Treatment:

Drug: LY3537031

Placebo Part B

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

LY3537031 Part C (Cohorts 12-15)

Experimental group

Description:

Multiple-ascending doses of LY3537031 administered SC

Treatment:

Drug: LY3537031

Placebo Part C

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

LY3537031 Part D (Cohorts 16-19)

Experimental group

Description:

Multiple-ascending doses of LY3537031 administered SC

Treatment:

Drug: LY3537031

Placebo Part D

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo