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Epic Medical Research | Red Oak, TX

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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 (ACHIEVE-4)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Drug: Orforglipron
Drug: Insulin Glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05803421
2022-502833-25-00 (Other Identifier)
18563
U1111-1285-6821 (Other Identifier)
J2A-MC-GZGS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

2,620 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have been diagnosed with type 2 diabetes mellitus (T2DM)

  • Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.

  • Have HbA1c at screening

    • ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
    • ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
  • Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas

  • Have increased risk for cardiovascular (CV) events due to:

    • Coronary heart disease
    • Peripheral arterial disease, presumed to be of atherosclerotic origin
    • Cerebrovascular disease, presumed to be of atherosclerotic origin
    • Chronic kidney disease (CKD)
    • Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
  • Are of stable weight (± 5%) for at least 90 days prior to screening

  • Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion criteria

  • Have type 1 diabetes mellitus
  • Have had chronic or acute pancreatitis any time prior to screening
  • Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
  • Have a known clinically significant gastric emptying abnormality
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
  • Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
  • Have an eGFR <15 mL/min/1.73 m2 as determined at screening
  • Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
  • Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,620 participants in 2 patient groups

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

Trial contacts and locations

393

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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