A Study of LY3841136 in Overweight and Obese Participants

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: LY3841136; Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06345066

18834

J3R-MC-YDAC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants who are overtly healthy as determined by medical evaluation
• Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).
• Have clinical laboratory test results within normal reference range
• Have venous access sufficient to allow for blood sampling
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

• Have type 1 or type 2 diabetes mellitus
• Have an abnormal 12-lead electrocardiogram (ECG)
• Have a history or presence of psychiatric disorders
• Have abnormal blood pressure and pulse rate
• Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

LY3841136 + Tirzepatide

Experimental group

Description:

LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.

Treatment:

Drug: Tirzepatide

Drug: LY3841136

Placebo + Tirzepatide

Placebo Comparator group

Description:

Placebo administered SC in combination with tirzepatide given SC.

Treatment:

Drug: Placebo

Drug: Tirzepatide