Clinical trial NCT05841238: A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
Official title: A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Obese
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970
timeFrame: Predose up to 92 days postdose
measure: PK: Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose up to 92 days postdose
measure: PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
timeFrame: Predose up to 92 days postdose
Secondary outcomes:
measure: PK: AUC[0-24] of LY3502970 in fed state
timeFrame: Predose up to 92 days postdose
measure: PK: Cmax of LY3502970 in fed state
timeFrame: Predose up to 92 days postdose
measure: PK: Tmax of LY3502970 in fed state
timeFrame: Predose up to 92 days postdose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: LabCorp CRU, Inc.
state: Florida
city: Dallas
country: United States
facility: Labcorp Clinical Research LP
state: Texas
city: Madison
country: United States
facility: LabCorp CRU, Inc.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: