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Completed

NCT Number: NCT05841238

A Multiple Dose Study 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.

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LabCorp CRU, Inc., Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3502970

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

    PK: AUC[0-24] of LY3502970 in fasted state

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

    PK: Cmax of LY3502970 in fasted state

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

    PK: Tmax of LY3502970 in fasted state

Secondary outcomes

  1. PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

    PK: AUC[0-24] of LY3502970 in fed state

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

    PK: Cmax of LY3502970 in fed state

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

    PK: Tmax of LY3502970 in fed state

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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