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 · Completed

Last updated 2026-05-28

This study is testing whether a daily oral medication called orforglipron is as effective as insulin glargine in reducing heart-related risks in adults with type 2 diabetes who also have obesity or are overweight and are at higher risk for cardiovascular disease.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 2,749 people

Who can join Ages 18+ · all sexes

Timeline Started 2023-04 · est. completion 2026-03

Where 358 sites · Argentina, Austria, Brazil, Czechia, Germany, Greece, India, Italy, Mexico, Puerto Rico, Romania, Slovakia, South Korea, Spain, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT05803421 ↗

Description as written by the study sponsor.

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

Treatments tested

Orforglipron also known as LY3502970 Drug

Administered orally once daily
Insulin Glargine Drug

Administered SC once daily

Main thing measured	Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Sponsor	Eli Lilly and Company
Conditions studied	Type 2 Diabetes, Obesity, Overweight or Obesity, Overweight, Cardiovascular Diseases, Chronic Kidney Disease
GLP-1 drugs	orforglipron

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05803421 ↗