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

NCT05841238 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18527J2A-MC-GZGN
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy; Obese

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  Predose up to 92 days postdose

• PK: Cmax of LY3502970 in fed state

  Predose up to 92 days postdose

• PK: Tmax of LY3502970 in fed state

  Predose up to 92 days postdose

Study Arms (2)

LY3502970 (Part A)

EXPERIMENTAL

The multiple doses of LY3502970 administered orally either in tablet or capsule formulations.

Drug: LY3502970

LY3502970 (Part B)

EXPERIMENTAL

The multiple doses of LY3502970 administered orally in tablet formulation.

Drug: LY3502970

Interventions

LY3502970 DRUG

Administered orally.

LY3502970 (Part A); LY3502970 (Part B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

LabCorp CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

Labcorp Clinical Research LP

Dallas, Texas, 75247, United States

Location

LabCorp CRU, Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part A open label. Part B double blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: April 26, 2023
• Primary Completion: September 14, 2023
• Study Completion: November 13, 2023
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)