A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Orforglipron; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06192108

2023-507206-13-00 (Other Identifier)

18566

U1111-1296-1507 (Other Identifier)

J2A-MC-GZGV (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.

Enrollment: 888 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
• Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
• Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization.
• Are of stable body 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 (T1D)
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
• Have an estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73 square meter (m2)
• Have acute or chronic hepatitis
• Have had chronic or acute pancreatitis any time.
• Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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888 participants in 4 patient groups

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

Dapagliflozin

Active Comparator group

Description:

Participants will receive dapagliflozin orally.

Treatment:

Drug: Dapagliflozin