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Trial · Interventional

CompletedPhase 3Registry data

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

Short name ACHIEVE-2

NCTNCT06192108 (opens ClinicalTrials.gov in a new tab)Other id18566Other idJ2A-MC-GZGVOther id2023-507206-13-00Other idU1111-1296-1507
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
962 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
6 countries

United States, China, Germany, Mexico, Poland, Taiwan

Start
10 Jan 2024
Primary completion
26 Sept 2025
Completion
26 Sept 2025
First posted
5 Jan 2024
Last update posted
20 Oct 2025
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 3

    ACHIEVE-2

    NCT06192108

    10 Jan 2024 to 26 Sept 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug
  • DapagliflozinDrug

Arms4

  • Experimental

    Orforglipron Dose 1

    Participants will receive orforglipron orally.

  • Experimental

    Orforglipron Dose 2

    Participants will receive orforglipron orally.

  • Experimental

    Orforglipron Dose 3

    Participants will receive orforglipron orally.

  • Active comparator

    Dapagliflozin

    Participants will receive dapagliflozin orally.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, Week 40

Secondary outcomes(16)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

10 results

Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial.

Welch et al. 2026Lancet (London, England)cited by 3

PMID 42259339DOI 10.1016/s0140-6736(26)00800-7PUB-42259339

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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