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ACHIEVE-5: A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06109311
Collaborator
(none)
520
Enrollment
35
Locations
4
Arms
19.4
Anticipated Duration (Months)
14.9
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
Anticipated Study Start Date :
Nov 13, 2023
Anticipated Primary Completion Date :
Apr 19, 2025
Anticipated Study Completion Date :
Jun 25, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orforglipron Dose 1

Participants will receive orforglipron orally.

Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970

    		•
    Experimental: Orforglipron Dose 2

    Participants will receive orforglipron orally.

    Drug: Orforglipron
    Administered orally.
    Other Names:
  • LY3502970

    		•
    Experimental: Orforglipron Dose 3

    Participants will receive orforglipron orally.

    Drug: Orforglipron
    Administered orally.
    Other Names:
  • LY3502970

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo orally.

    Drug: Placebo
    Administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 40]

    Secondary Outcome Measures

    1. Orforglipron Dose 3: Change from Baseline in HbA1c [Baseline, Week 40]

    2. Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol)) [Baseline to Week 40]

    3. Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) [Baseline to Week 40]

    4. Change from Baseline in Fasting Serum Glucose [Baseline, Week 40]

    5. Percentage Change from Baseline in Body Weight [Baseline, Week 40]

    6. Change from Baseline in Body Weight [Baseline, Week 40]

    7. Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol [Baseline, Week 40]

    8. Percentage Change from Baseline in Triglycerides [Baseline, Week 40]

    9. Change from Baseline in Systolic Blood Pressure [Baseline, Week 40]

    10. Change from Baseline in Daily Insulin Glargine Dose [Baseline, Week 40]

    11. Percentage of Participants Who Achieved Weight Loss of ≥5% [Baseline to Week 40]

    12. Percentage of Participants Who Achieved Weight Loss of ≥10% [Baseline to Week 40]

    13. Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline [Baseline to Week 40]

    14. Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores [Baseline, Week 40]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have Type 2 Diabetes (T2D)

    • Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]

    • Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:

    • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or

    • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with

    • metformin, or

    • SGLT-2 inhibitor, or

    • both metformin and SGLT-2 inhibitor.

    • Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 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 kg/m^2 at baseline.

    Exclusion Criteria:

    • Have New York Heart Association functional classification III-IV congestive heart failure.

    • Have had any of the following cardiovascular conditions within 60 days prior to baseline.

    • acute myocardial infarction

    • cerebrovascular accident (stroke), or

    • hospitalization for congestive heart failure.

    • Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease

    • Have had chronic or acute pancreatitis any time.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD First Research - Chandler Chandler Arizona United States 85286
    2 Phoenix Clinical LLC Phoenix Arizona United States 85014
    3 SanRo Clinical Research Group Bryant Arkansas United States 72022
    4 Loma Linda University Health System Loma Linda California United States 92354
    5 Western University of Health Sciences Pomona California United States 91766
    6 Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. Toluca Lake California United States 91602
    7 CMR of Greater New Haven, LLC Hamden Connecticut United States 06517
    8 Encore Medical Research Hollywood Florida United States 33021
    9 Encore Medical Research - Weston Weston Florida United States 33331
    10 Orita Clinical Research Decatur Georgia United States 30034
    11 Balanced Life Health Care Solutions/SKYCRNG Lawrenceville Georgia United States 30046
    12 Bingham Memorial Hospital Blackfoot Idaho United States 83221
    13 Humphreys Diabetes Center Boise Idaho United States 83702
    14 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
    15 Clinvest Research LLC Springfield Missouri United States 65807
    16 Tristar Clinical Investigations Philadelphia Pennsylvania United States 19114
    17 Frontier Clinical Research, LLC Scottdale Pennsylvania United States 15683
    18 Lifedoc Research - Lenox Park Drive Memphis Tennessee United States 38115
    19 Texas Valley Clinical Research Weslaco Texas United States 78596
    20 L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192 Brasília Distrito Federal Brazil 70200730
    21 CEDOES Vitória Espírito Santo Brazil 29055450
    22 Centro Multidisciplinar de Estudos Clinicos Sao Bernardo do Campo São Paulo Brazil 09715-090
    23 IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil 20241-180
    24 Hasegawa Medical Clinic Chitose Hokkaido Japan 066-0032
    25 MinamiAkatsukaClinic Mito Ibaraki Japan 311-4153
    26 Matoba Internal Medicine Clinic Ebina Kanagawa Japan 243-0432
    27 Takai Internal Medicine Clinic Kamakura-shi Kanagawa Japan 247-0056
    28 Shiraiwa Medical Clinic Kashiwara Osaka Japan 582-0005
    29 The Institute for Adult Disease, Asahi Life Foundation Chuo-ku Tokyo Japan 103-0002
    30 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    31 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    32 Medical Corporation Sato Medical clinic Ootaku Tokyo Japan 143-0015
    33 Jinnouchi Hospital Kumamoto Japan 862-0976
    34 Kansai Electric Power Hospital Osaka Japan 553-0003
    35 Centro de Endocrinologia y Nutricion Caguas Puerto Rico 00725

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT06109311
    Other Study ID Numbers:
    • 18567
    • J2A-MC-GZGW
    • U1111-1294-2797
    • 2023-507280-18-00
    First Posted:
    Oct 31, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 15, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Oct 31, 2023