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Trial record 1 of 1 for:    J2A-MC-GZGT
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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)

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Orforglipron Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 9, 2023
Estimated Primary Completion Date : April 9, 2025
Estimated Study Completion Date : April 9, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
 Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
 Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally.
 Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Placebo Comparator: Placebo
Participants will receive placebo orally.
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

Secondary Outcome Measures :
  1. Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) [ Time Frame: Week 40 ]
  2. Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol) [ Time Frame: Week 40 ]
  3. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, 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. Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, Week 40 ]
  7. Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 40 ]
  8. Change from Baseline in Non-HDL Cholesterol [ Time Frame: Baseline, Week 40 ]
  9. Percentage Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 40 ]
  10. Percentage of Participants Who Achieved Weight Loss of ≥5% [ Time Frame: Week 40 ]
  11. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores [ Time Frame: Baseline, Week 40 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05971940


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05971940    
Other Study ID Numbers: 18564
J2A-MC-GZGT ( Other Identifier: Eli Lilly and Company )
U1111-1290-5157 ( Other Identifier: UTN Number )
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases