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OpenTrials
Completed

NCT Number: NCT06192108

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second People's Hospital of Hefei, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Dapagliflozin

Drug

Administered orally

Primary outcomes

  1. Change from Baseline in Hemoglobin A1c: (HbA1c)

    Time frame: Baseline, Week 40

Secondary outcomes

  1. Change from Baseline in HbA1c

    Time frame: Baseline, Week 40

  2. Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))

    Time frame: Week 40

  3. Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)

    Time frame: Week 40

  4. Percentage Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

  5. Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

  6. Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol

    Time frame: Baseline, Week 40

  7. Percentage Change from Baseline in Triglycerides

    Time frame: Baseline, Week 40

  8. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 40

  9. Change from Baseline in Fasting Serum Glucose

    Time frame: Baseline, Week 40

  10. Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline

    Time frame: Baseline to Week 40

  11. Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline

    Time frame: Baseline to Week 40

  12. Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline

    Time frame: Baseline to Week 40

  13. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 40

  14. Percentage Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 40

  15. Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores

    Time frame: Baseline, Week 40

  16. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores

    Time frame: Baseline, Week 40

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)

Acronym: ACHIEVE-2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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