Trial results

A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

NCT05803421 on ClinicalTrials.gov · last registry update 2026-04-17

An unusually large phase 3: 2,749 participants, more than double the 424 typical for the stage. Completed 16 March 2026. orforglipron is approved in the US, but not for cardiovascular disease and chronic kidney disease — a registration here is not an approval, and most drugs tested in a new condition never get one for it.

Status

COMPLETED

Phase

P3

Drug

orforglipron

Foundayo

Sponsor

Eli Lilly and Company

Sponsor type

Industry

Enrollment

2,749

Started

2023-04-03

Primary completion

2026-03-16 actual

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

Primary outcome

Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]

Conditions studied

Type 2 Diabetes · Obesity · Overweight or Obesity · Overweight · Cardiovascular Diseases · Chronic Kidney Disease

Every field above is taken directly from the registry record. See all detected changes across the class, or the orforglipron page for this molecule’s full trial and approval history.