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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05971940
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 25, 2023
First Posted Date  ICMJE August 2, 2023
Last Update Posted Date April 16, 2024
Actual Study Start Date  ICMJE August 9, 2023
Estimated Primary Completion Date April 9, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2023)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2023)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 40 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2023)
  • Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) [ Time Frame: Week 40 ]
  • Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol) [ Time Frame: Week 40 ]
  • Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 40 ]
  • Percentage Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Non-HDL Cholesterol [ Time Frame: Baseline, Week 40 ]
  • Percentage Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 40 ]
  • Percentage of Participants Who Achieved Weight Loss of ≥5% [ Time Frame: Week 40 ]
  • Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores [ Time Frame: Baseline, Week 40 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2023)
  • Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) [ Time Frame: Week 40 ]
  • Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol) [ Time Frame: Week 40 ]
  • Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 40 ]
  • Percentage Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 40 ]
  • Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 40 ]
  • Percentage of Participants Who Achieved Weight Loss of ≥5% [ Time Frame: Week 40 ]
  • Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores [ Time Frame: Baseline, Week 40 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Orforglipron
    Administered orally.
    Other Name: LY3502970
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: Orforglipron Dose 1
    Participants will receive orforglipron orally.
    Intervention: Drug: Orforglipron
  • Experimental: Orforglipron Dose 2
    Participants will receive orforglipron orally.
    Intervention: Drug: Orforglipron
  • Experimental: Orforglipron Dose 3
    Participants will receive orforglipron orally.
    Intervention: Drug: Orforglipron
  • Placebo Comparator: Placebo
    Participants will receive placebo orally.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2023)
520
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 9, 2025
Estimated Primary Completion Date April 9, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE China,   India,   Japan,   Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05971940
Other Study ID Numbers  ICMJE 18564
J2A-MC-GZGT ( Other Identifier: Eli Lilly and Company )
U1111-1290-5157 ( Other Identifier: UTN Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP