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CompletedPhase 1

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

A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

7

Recruiting sites

Enrollment

533

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 27-40Healthy volunteers

Primary endpoint

Part B

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06440980
Org study ID18617
Secondary IDJ2A-MC-GZPIEli Lilly and Company

Timeline

Milestones

Study first posted2024-06-04actual
Study start2024-06-24actual
Primary completion2025-06-02actual
Study completion2025-06-02actual
Last update posted2025-06-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

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

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

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

Cmax

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.