A Study of LY3841136 in Healthy and Overweight Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Obesity

Treatments: Drug: Placebo; Drug: LY3841136

Study type: Interventional

Funder types: Industry

Identifiers

NCT05295940

18309

J3R-MC-YDAA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.

Enrollment: 148 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
• Have had a stable weight for the last 3 months
• Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Exclusion criteria

• Are women who are lactating
• Have known allergies to related compounds of LY3841136 or any components of the formulation
• Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
• Have been diagnosed with Type 1 or Type 2 diabetes mellitus
• Have a history of chronic medical conditions involving the heart, liver, or kidneys

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 4 patient groups, including a placebo group

LY3841136 (Part A)

Experimental group

Description:

Single ascending doses of LY3841136 administered subcutaneously (SC).

Treatment:

Drug: LY3841136

LY3841136 (Part B)

Experimental group

Description:

Multiple ascending doses of LY3841136 administered SC.

Treatment:

Drug: LY3841136

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo