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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Orforglipron — DRUG
  Administered orally once daily
• Insulin Glargine — DRUG
  Administered SC once daily

Study Details

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.

Key Dates

Start date

Apr 3, 2023

Status verified

Apr 2026

Primary completion

Mar 16, 2026

Completion

Mar 16, 2026

Study Design

Enrollment

2,749 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Orforglipron
  Participants will receive escalated doses of orforglipron orally.
• Active Comparator: Insulin Glargine
  Participants will receive insulin glargine subcutaneously (SC). Doses will be individualized and titrated according to a treat-to-target algorithm.

Primary Outcome Measure

Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death] [ Time Frame: Baseline to End of the Study (Approximate Maximum 104 Weeks) ]

Locations (173)

Related coverage on Hipa.ai

• Orforglipron Phase 3 Trial for Type 2 Diabetes and Obesity Completes Primary…
  Orforglipron · Mar 16, 2026 · ClinicalTrials.gov

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