Study S001593

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.

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT06440980
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 533
Start: 2024-06-24
Primary completion: 2025-06-02
Lead sponsor: Eli Lilly and Company
Conditions: Healthy; Obese; Overweight; Obesity
Interventions: DRUG:Orforglipron
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:J2A-MC-GZPI

Registered primary outcomes

Part B: Pharmacokinetics (PK): Steady-state Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau]) of LY3502970 on Day 7 [Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)]
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7 [Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0012198	Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight. Ma X, Diabetes, obesity & metabolism	2026	Other trial	PMID 41994902 DOI	cites ClinicalTrials.gov:NCT06440980; registry reference DERIVED:41994902