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

NCT05841238 | Completed Phase 1 Results 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 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

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

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

  PK: Cmax of LY3502970 in fasted state

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

  PK: Tmax of LY3502970 in fasted state

  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

Secondary Outcomes (3)

• 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

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

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

  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)

Study Arms (4)

Part A: LY3502970 (Periods 1 to 11)

EXPERIMENTAL

Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows: * Period 1 (Day 1-7): 0.8 milligram (mg) LY3502970 tablet (fasted state) * Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state) * Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state) * Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state) * Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state) * Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state) * Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state) * Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state) * Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state) * Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state) * Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state)

Drug: LY3502970

Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)

EXPERIMENTAL

Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state)

Drug: LY3502970

Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)

EXPERIMENTAL

Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state)

Drug: LY3502970

Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)

EXPERIMENTAL

Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 36 mg LY3502970 dual-fill (DF) capsule (fasted state) * Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state)

Drug: LY3502970

Interventions

LY3502970 DRUG

Administered orally.

Part A: LY3502970 (Periods 1 to 11); Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13); Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13); Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-595-5979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part A open label. Part B double blinded (Investigator and Participant 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: July 10, 2026
• Results First Posted: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)