Obesity, Overweight
Conditions
Keywords
Safety, Tolerability, Body weight
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136 | Predose up to 42 weeks |
| 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 |
Countries
United States
Outcome results
None listed