NCT06345066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Apr 2024

Typical duration for phase_1 obesity

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

March 28, 2024

Last Update Submit

October 14, 2025

Conditions

ObesityOverweight

Keywords

SafetyTolerabilityBody weight

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

LY3841136 + Tirzepatide

EXPERIMENTAL

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

Drug: TirzepatideDrug: LY3841136

Placebo + Tirzepatide

PLACEBO COMPARATOR

Placebo administered SC in combination with tirzepatide given SC.

Drug: TirzepatideDrug: Placebo

Interventions

TirzepatideDRUG

Administered SC.

LY3841136 + TirzepatidePlacebo + Tirzepatide
LY3841136DRUG

Administered SC.

LY3841136 + Tirzepatide
PlaceboDRUG

Administered SC.

Placebo + Tirzepatide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweightBody Weight

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

April 3, 2024

Primary Completion

September 29, 2025

Study Completion

September 29, 2025

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)