A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obese
• Intervention / Treatment: Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • LabCorp CRU, Inc.
  • Texas
    • Dallas, Texas, United States, 75247
      • Labcorp Clinical Research LP
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • LabCorp CRU, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3502970 (Part A); The multiple doses of LY3502970 administered orally either in tablet or capsule formulations.	Drug: LY3502970; Administered orally.
Experimental: LY3502970 (Part B); The multiple doses of LY3502970 administered orally in tablet formulation.	Drug: LY3502970; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970	PK: AUC[0-24] of LY3502970	Predose up to 92 days postdose
PK: Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 92 days postdose
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Predose up to 92 days postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK: AUC[0-24] of LY3502970 in fed state	PK: AUC[0-24] of LY3502970 in fed state	Predose up to 92 days postdose
PK: Cmax of LY3502970 in fed state	PK: Cmax of LY3502970 in fed state	Predose up to 92 days postdose
PK: Tmax of LY3502970 in fed state	PK: Tmax of LY3502970 in fed state	Predose up to 92 days postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 18527; J2A-MC-GZGN (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No