A Study of LY3841136 in Overweight and Obese Participants

Phase 1

Active, not recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Tirzepatide; Drug: Placebo; Drug: LY3841136

• Registration Number: NCT06345066
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study Start: 2024-04-03
• Study First Posted: 2024-04-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Tirzepatide	Placebo	Placebo administered SC in combination with tirzepatide given SC.
LY3841136 + Tirzepatide	LY3841136	LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.
Placebo + Tirzepatide	Tirzepatide	Placebo administered SC in combination with tirzepatide given SC.
LY3841136 + Tirzepatide	Tirzepatide	LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.

Primary Outcome Measures

Name	Time	Method
Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration	Baseline up to 42 weeks	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in body weight	Baseline, Week 42
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136	Predose up to 42 weeks
Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136	Predose up to 42 weeks

Trial Locations

Locations (1)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States