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

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Overweight; Obese; Healthy; Obesity

Treatments: Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06440980

J2A-MC-GZPI (Other Identifier)

18617

Details and patient eligibility

About

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.

Enrollment: 508 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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508 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Orforglipron

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

Experimental group

Description:

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

Treatment:

Drug: Orforglipron