A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes (ACHIEVE-J)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06010004

J2A-JE-GZPE (Other Identifier)

18745

Details and patient eligibility

About

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

This study includes 3 periods as follows:

• screening and lead-in period: up to 4 weeks
• treatment period: 52 weeks, including 20 weeks of dose escalation, and
• safety follow-up period: 2 weeks.

Enrollment: 401 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) as determined by the central laboratory at screening.
• Are of stable weight (±5%) for at least 90 days prior to screening 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion criteria

• Have Type 1 Diabetes (T1D).

• Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.

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

• Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.

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

• Have acute or chronic hepatitis and pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 3 patient groups

3 mg Orforglipron

Experimental group

Description:

Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.

Treatment:

Drug: Orforglipron

12 mg Orforglipron

Experimental group

Description:

Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.

Treatment:

Drug: Orforglipron

36 mg Orforglipron

Experimental group

Description:

Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Treatment:

Drug: Orforglipron