A Study of LY3841136 in Overweight and Obese Participants

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345066
• Other study ID #: 18834
• Secondary ID: J3R-MC-YDAC
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Obesity
• Overweight

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

External Links

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