A Study of LY3841136 in Overweight and Obese Participants

A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: LY3841136; Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + Tirzepatide; Placebo administered SC in combination with tirzepatide given SC.	Drug: Placebo; Administered SC.; Drug: Tirzepatide; Administered SC.
Experimental: LY3841136 + Tirzepatide; LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.	Drug: LY3841136; Administered SC.; Drug: Tirzepatide; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.	Baseline up to 42 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percent change from baseline in body weight	Baseline, Week 42

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): September 29, 2025
• Study Completion (Actual): September 29, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Body weight
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Body Weight; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 18834; J3R-MC-YDAC (Other Identifier: Eli Lilly And Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No