A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
- Registration Number
- NCT05841238
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Male or female participants who are overtly healthy as determined by medical evaluation
- Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
- Participants with a stable body weight, with 5% or less body weight gain or loss
- Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
- Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
- Have known clinically significant gastric emptying abnormality
- Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
- Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug
- Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3502970 (Part A) LY3502970 The multiple doses of LY3502970 administered orally either in tablet or capsule formulations. LY3502970 (Part B) LY3502970 The multiple doses of LY3502970 administered orally in tablet formulation.
- Primary Outcome Measures
Name Time Method PK: Maximum Observed Concentration (Cmax) of LY3502970 Predose up to 92 days postdose PK: Cmax of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 Predose up to 92 days postdose PK: Tmax of LY3502970
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 Predose up to 92 days postdose PK: AUC\[0-24\] of LY3502970
- Secondary Outcome Measures
Name Time Method PK: Tmax of LY3502970 in fed state Predose up to 92 days postdose PK: Tmax of LY3502970 in fed state
PK: Cmax of LY3502970 in fed state Predose up to 92 days postdose PK: Cmax of LY3502970 in fed state
PK: AUC[0-24] of LY3502970 in fed state Predose up to 92 days postdose PK: AUC\[0-24\] of LY3502970 in fed state
Trial Locations
- Locations (2)
LabCorp CRU, Inc.
🇺🇸Madison, Wisconsin, United States
Labcorp Clinical Research LP
🇺🇸Dallas, Texas, United States