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ACHIEVE-J: A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010004
Collaborator
(none)
399
Enrollment
41
Locations
3
Arms
20.8
Anticipated Duration (Months)
9.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

This study includes 3 periods as follows:

  • screening and lead-in period: up to 4 weeks

  • treatment period: 52 weeks, including 20 weeks of dose escalation, and

  • safety follow-up period: 2 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
399 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)
Anticipated Study Start Date :
Sep 11, 2023
Anticipated Primary Completion Date :
Jun 4, 2025
Anticipated Study Completion Date :
Jun 4, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orforglipron Dose 1

Participants will receive orforglipron administered orally.

Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

    		•
    Experimental: Orforglipron Dose 2

    Participants will receive orforglipron administered orally.

    Drug: Orforglipron
    Administered orally
    Other Names:
  • LY3502970

    		•
    Experimental: Orforglipron Dose 3

    Participants will receive orforglipron administered orally.

    Drug: Orforglipron
    Administered orally
    Other Names:
  • LY3502970

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Baseline through Week 52]

    Secondary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 52]

    2. Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol) [Week 52]

    3. Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol) [Week 52]

    4. Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol) [Week 52]

    5. Change from Baseline in Fasting Serum Glucose [Baseline, Week 52]

    6. Change from Baseline in Body Weight [Baseline, Week 52]

    7. Percentage of Participants who Achieve Weight Loss of ≥5% [Week 52]

    8. Percentage of Participants who Achieve Weight Loss of ≥10% [Week 52]

    9. Percentage of Participants who Achieve Weight Loss of ≥15% [Week 52]

    10. Change from Baseline in Waist Circumference [Baseline, Week 52]

    11. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 52]

    12. Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) [Baseline, Week 52]

    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) as determined by the central laboratory at screening.

    • 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

    Exclusion Criteria:

    • Have Type 1 Diabetes (T1D).

    • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.

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

    • Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.

    • acute myocardial infarction

    • cerebrovascular accident (stroke), or

    • hospitalization for congestive heart failure

    • Have acute or chronic hepatitis and pancreatitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nakayama Clinic Nagoya Aichi Japan 456-0058
    2 Shinkashiwa Clinic Kashiwa Chiba Japan 277-0084
    3 Kashiwa City Hospital Kashiwa Chiba Japan 277-0825
    4 Mikannohana Clinic, Diabetes, Endocrinology and Metabolism Matsuyama Ehime Japan 116099
    5 Steel Memorial Yawata Hospital Kitakyushu Fukuoka Japan 805-8508
    6 Hasegawa Medical Clinic Chitose Hokkaido Japan 066-0032
    7 Odori Diabetes Sapporo Hokkaido Japan 060-0001
    8 Matsuda Clinic Kobe Hyogo Japan 651-2135
    9 Nakamoto Internal Medicine Clinic Mito Ibaraki Japan 310-0826
    10 MinamiAkatsukaClinic Mito Ibaraki Japan 311-4153
    11 Nakakinen clinic Naka Ibaraki Japan 311-0113
    12 Nishiyamadou Keiwa Hospital Naka Ibaraki Japan 311-0133
    13 Taya Clinic Koueikai Medical Corporation Tsuchiura Ibaraki Japan 300-0047
    14 Takai Internal Medicine Clinic Kamakura-shi Kanagawa Japan 247-0056
    15 Shonan Takai Clinic Kamakura Kanagawa Japan 247-0055
    16 Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa Japan 242-0004
    17 Yokohama Minoru Clinic Yokohama Kanagawa Japan 232-0064
    18 Yokkaichi Diabetes Clinic Yokkaichi Mie Japan 510-0829
    19 Gibo Hepatology Clinic Matsumoto Nagano Japan 399-0036
    20 Shiraiwa Medical Clinic Kashiwara Osaka Japan 582-0005
    21 Kitada Clinic Osaka-city Osaka Japan 538-0044
    22 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    23 OHAMA Diabetes Clinic Kawaguchi Saitama Japan 332-0015
    24 Sugiura Internal Medicine Clinic Soka Saitama Japan 340-0034
    25 Seiwa Clinic Adachi-ku Tokyo Japan 120-0011
    26 The Institute of Medical Science, Asahi Life Foundation Chuo-ku Tokyo Japan 103-0002
    27 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    28 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    29 Hachioji Diabetes Clinic Hachioji-shi Tokyo Japan 192-0083
    30 Kanno Naika Mitaka Tokyo Japan 181-0013
    31 Medical Corporation Heishinkai ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
    32 Medical Corporation Tao Internal Medicine Clinic Ube Yamaguchi Japan 755-0047
    33 Fujii Clinic Ube Yamaguchi Japan 755-0049
    34 Tokuyama Clinic Chiba Japan 261-0004
    35 Tashiro Endocrinology Clinic Fukuoka Japan 814-0153
    36 Morinaga Ueno Clinic Kumamoto Japan 860-0863
    37 Jinnouchi Hospital Kumamoto Japan 862-0976
    38 Heiwadai Hospital Miyazaki Japan 880-0034
    39 Abe Clinic Oita Japan 870-0039
    40 AMC Nishiumeda Clinic Osaka Japan 530-0001
    41 Kansai Electric Power Hospital Osaka Japan 553-0003

    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:
    NCT06010004
    Other Study ID Numbers:
    • 18745
    • J2A-JE-GZPE
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Aug 24, 2023