A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (ACHIEVE-5)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06109311

U1111-1294-2797 (Other Identifier)

J2A-MC-GZGW (Other Identifier)

18567

2023-507280-18-00 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Enrollment: 520 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Type 2 Diabetes (T2D)

• Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]

• Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:

  • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
  • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
  • metformin, or
  • SGLT-2 inhibitor, or
  • both metformin and SGLT-2 inhibitor.

• Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.

• Have a Body Mass Index (BMI) ≥23.0 kg/m^2 at baseline.

Exclusion criteria

• Have New York Heart Association functional classification III-IV congestive heart failure.

• Have had any of the following cardiovascular conditions within 60 days prior to baseline.

  • acute myocardial infarction
  • cerebrovascular accident (stroke), or
  • hospitalization for congestive heart failure.

• Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease

• Have had chronic or acute pancreatitis any time.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 4 patient groups, including a placebo group

Orforglipron Dose 1

Experimental group

Description:

Participants will receive orforglipron orally.

Treatment:

Drug: Orforglipron

Orforglipron Dose 2

Experimental group

Description:

Participants will receive orforglipron orally.

Treatment:

Drug: Orforglipron

Orforglipron Dose 3

Experimental group

Description:

Participants will receive orforglipron orally.

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally.

Treatment:

Drug: Placebo