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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06345066
Other study ID # 18834
Secondary ID J3R-MC-YDAC
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 3, 2024
Est. completion date March 2025

Study information

Verified date April 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 13176154559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Tirzepatide
Administered SC.
LY3841136
Administered SC.
Placebo
Administered SC.

Locations

Country Name City State
United States Fortrea CRU, Inc. Dallas Texas
United States Fortrea CRU, Inc. Daytona Beach Florida
United States Fortrea CRU, Inc. Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percent Change from Baseline in Body Weight Baseline, Week 42
Secondary Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136 Predose up to 42 weeks
Secondary Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136 Predose up to 42 weeks
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