A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT05971940

18564

J2A-MC-GZGT (Other Identifier)

U1111-1290-5157 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Enrollment: 559 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Type 2 Diabetes
• Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
• Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
• 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 body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion criteria

• Have Type 1 Diabetes
• Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
• Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
• Have New York Heart Association functional classification IV congestive heart failure.
• Have acute or chronic pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

559 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.

Treatment:

Drug: Placebo

3 mg Orforglipron

Experimental group

Description:

Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.

Treatment:

Drug: Orforglipron

12 mg Orforglipron

Experimental group

Description:

Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.

Treatment:

Drug: Orforglipron

36 mg Orforglipron

Experimental group

Description:

Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.

Treatment:

Drug: Orforglipron