A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

NCT06045221
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
1,698
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2023-09-22
clinicaltrials.gov
Number of sites
131
clinicaltrials.gov

Summary
The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.
clinicaltrials.gov
Acronym
ACHIEVE-3
clinicaltrials.gov
Short title
A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
clinicaltrials.gov
Official title
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2025-08-22
clinicaltrials.gov
First posted
2023-09-21
clinicaltrials.gov
Registry last updated
2025-09-22
clinicaltrials.gov
Primary completion date
2025-08-22
clinicaltrials.gov
Start date
2023-09-22
clinicaltrials.gov

Actual participants
1,698
clinicaltrials.gov
Participants
1,698
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
131
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06045221
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06045221
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline, Week 52

  1. Change from Baseline in HbA1c

    Timeframe: Baseline, Week 52

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

    Timeframe: Week 52

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

    Timeframe: Week 52

  4. Percentage Change from Baseline in Body Weight

    Timeframe: Baseline, Week 52

  5. Change from Baseline in Body Weight

    Timeframe: Baseline, Week 52

  6. Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol)

    Timeframe: Week 52

  7. Change from Baseline in Fasting Serum Glucose

    Timeframe: Baseline, Week 52

  8. Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG)

    Timeframe: Baseline, Week 52

  9. Percentage of Participants Who Achieved Weight Loss of ≥5%

    Timeframe: Week 52

  10. Percentage of Participants Who Achieved Weight Loss of ≥10%

    Timeframe: Week 52

  11. Percentage of Participants Who Achieved Weight Loss of ≥15%

    Timeframe: Week 52

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

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 52

  14. Percentage Change from Baseline in Total Cholesterol

    Timeframe: Baseline, Week 52

  15. Percentage Change from Baseline in High Density Lipoprotein (HDL)-Cholesterol

    Timeframe: Baseline, Week 52

  16. Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol

    Timeframe: Baseline, Week 52

  17. Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol

    Timeframe: Baseline, Week 52

  18. Percentage Change from Baseline in Non-HDL-Cholesterol

    Timeframe: Baseline, Week 52

  19. Percentage Change from Baseline in Triglycerides

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Have Type 2 Diabetes
  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
  • Have been on stable diabetes treatment with metformin ≥1500 milligram (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 Type 1 Diabetes
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
  • Have a New York Heart Association functional classification IV congestive heart failure.
  • Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
  • Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
Sources for eligibility
clinicaltrials.gov

  • Absolute Clinical ResearchPhoenix, United States
  • San Fernando Valley Health InstituteCanoga Park, United States
  • Neighborhood Healthcare Institute of HealthEscondido, United States
  • Velocity Clinical Research, GardenaGardena, United States
  • Biopharma Informatic, LLCLos Angeles, United States
  • Velocity Clinical Research, WestlakeLos Angeles, United States
  • Infinity Clinical Research - NorcoNorco, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Norcal Endocrinology & Internal MedicineSan Ramon, United States
  • Encompass Clinical ResearchSpring Valley, United States
  • University Clinical Investigators, Inc.Tustin, United States
  • New West Physicians Clinical ResearchGolden, United States
  • Connecticut Clinical Research - CromwellCromwell, United States
  • Clinical Research of West Florida, Inc. (Clearwater)Clearwater, United States
  • South Florida Clinical Research InstituteMargate, United States
  • Miami Dade Medical Research Institute, LLCMiami, United States
  • West Orange EndocrinologyOcoee, United States
  • Latin Clinical Trial Center FloridaTamarac, United States
  • Clinical Research of West FloridaTampa, United States
  • Metabolic Research Institute, Inc.West Palm Beach, United States
  • Balanced Life Health Care Solutions/SKYCRNGLawrenceville, United States
  • Clinical Research AtlantaStockbridge, United States
  • North Georgia Clinical ResearchWoodstock, United States
  • Northwest Clinical TrialsBoise, United States
  • Family First Medical CenterIdaho Falls, United States

And 106 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1290-6014
  • J2A-MC-GZGU
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)