A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
LY3841136 + Tirzepatide
LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.
Intervention: Tirzepatide (Drug)
LY3841136 + Tirzepatide
LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.
Intervention: LY3841136 (Drug)
Placebo + Tirzepatide
Placebo administered SC in combination with tirzepatide given SC.
Intervention: Tirzepatide (Drug)
Placebo + Tirzepatide
Placebo administered SC in combination with tirzepatide given SC.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)