A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

NCT06440980 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18617J2A-MC-GZPI
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 7

Brief Summary

The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.

Conditions

Healthy; Obese; Overweight; Obesity

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths

  τ is 24 hours for once daily (QD) dosing

  Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)

• Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths

  Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)

Secondary Outcomes (2)

• Part B: PK: Steady-state AUC(0-τ) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths

  Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)

• Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths

  Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)

Study Arms (2)

Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron

EXPERIMENTAL

Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels.

Drug: Orforglipron

Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron

EXPERIMENTAL

Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6).

Drug: Orforglipron

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron; Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron

Eligibility Criteria

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

You may qualify if:

• Participants who are overtly healthy as determined by medical history and physical examination.
• Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²).
• Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
• Have venous access sufficient to allow for blood sampling.

You may not qualify if:

• Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
• Have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions.
• Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years.
• 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)
• Have a 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 an abnormal 12-lead electrocardiogram (ECG) at screening.
• Have history of pancreatitis.
• Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).
• Have difficulty swallowing capsules or tablets.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Altasciences Company Inc.

Overland Park, Kansas, 66212, United States

Location

QPS

Springfield, Missouri, 65802, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Links

• A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

MeSH Terms

Conditions

Obesity; Overweight

Interventions

orforglipron

Condition Hierarchy (Ancestors)

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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: June 24, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)