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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2025-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Obese Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

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

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

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Interventions

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Orforglipron

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3502970

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes