Clincosm LogoSign in Get a demo

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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05971940
Collaborator
(none)
520
Enrollment
92
Locations
4
Arms
17.1
Anticipated Duration (Months)
5.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
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 LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2025
Anticipated Study Completion Date :
Jan 15, 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.

    Drug: Placebo
    Administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Week 40]

    Secondary Outcome Measures

    1. Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) [Week 40]

    2. Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol) [Week 40]

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

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

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

    6. Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) [Baseline, Week 40]

    7. Change from Baseline in Systolic Blood Pressure (SBP) [Baseline, Week 40]

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

    9. Percentage of Participants Who Achieved Weight Loss of ≥5% [Week 40]

    10. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain 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

    • 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 hepatitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Syed Research Consultants Llc Sheffield Alabama United States 35660
    2 Epic Medical Research - Surprise Surprise Arizona United States 85378
    3 Quality of Life Medical & Research Center Tucson Arizona United States 85712
    4 Neighborhood Healthcare Institute of Health Escondido California United States 92025
    5 Velocity Clinical Research, Huntington Park Huntington Park California United States 90255
    6 Ark Clinical Research Long Beach California United States 90815
    7 Velocity Clinical Research, Westlake Los Angeles California United States 90057
    8 Infinity Clinical Research - Norco Norco California United States 92860
    9 Norcal Endocrinology & Internal Medicine San Ramon California United States 94583
    10 University Clinical Investigators, Inc. Tustin California United States 92780
    11 Connecticut Clinical Research - Cromwell Cromwell Connecticut United States 06416
    12 Invictus Clinical Research Group Coconut Creek Florida United States 33073
    13 Hillcrest Medical Research DeLand Florida United States 32720
    14 K2 Medical Research Maitland Florida United States 32751
    15 Global Health Research Center, Inc. Miami Lakes Florida United States 33016
    16 West Orange Endocrinology Ocoee Florida United States 34761
    17 Clinical Research Atlanta Stockbridge Georgia United States 30281
    18 Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia United States 30291
    19 Family First Medical Center Idaho Falls Idaho United States 83404
    20 Tekton Research, Inc Wichita Kansas United States 67218
    21 Alliance for Multispecialty Research, LLC New Orleans Louisiana United States 70119
    22 Revival Research Institute Dearborn Michigan United States 48126
    23 Billings Clinic Billings Montana United States 59101
    24 Synexus Clinical Research US Henderson Nevada United States 89052
    25 Ellipsis Research Group Brooklyn New York United States 11215
    26 Central New York Clinical Research Manlius New York United States 13104
    27 Monroe Biomedical Research Monroe North Carolina United States 28112
    28 Lucas Research - New Bern New Bern North Carolina United States 28562
    29 Aventiv Research Dublin Ohio United States 43016
    30 Alliance for Multispecialty Research, LLC Norman Oklahoma United States 73069
    31 The Corvallis Clinic, P.C. Corvallis Oregon United States 97330
    32 Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Pittsburgh Pennsylvania United States 15243
    33 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
    34 The Research Center of The Upstate Greenville South Carolina United States 29607
    35 MD First Research Lancaster South Carolina United States 29720
    36 The Jackson Clinic Jackson Tennessee United States 38305
    37 DiscoveResearch Beaumont Texas United States 77701
    38 Velocity Clinical Research, Dallas Dallas Texas United States 75230
    39 Endocrine Ips, Pllc Houston Texas United States 77079
    40 Amir A Hassan, MD, PA Houston Texas United States 77089
    41 Burke Internal Medicine and Research Burke Virginia United States 22015
    42 Wannan Medical College Yijishan Hospital Wuhu Anhui China 241001
    43 Luhe Hospital Beijing Beijing China 100000
    44 Beijing Hospital Beijing Beijing China 100730
    45 Beijing Pinggu District Hospital Beijing Beijing China 101200
    46 Shunde Hospital of Southern Medical Univesity Foshan Guangdong China 528399
    47 Huizhou Municipal Central Hospital Huizhou Guangdong China 516001
    48 Nanyang First People's Hospital Nanyang Henan China 473014
    49 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    50 Nanjing First Hospital Nanjing Jiangsu China 210006
    51 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    52 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
    53 The Affiliated Hospital of Beihua University Jilin Jilin China 132000
    54 Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Liaoning China 116033
    55 The Fourth Hospital of Harbin Medical University Harbin Nangang District China 150001
    56 Jinan Central Hospital Jinan Shandong China 250013
    57 Pudong New Area People's Hospital Shanghai Shanghai Shanghai China 201200
    58 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    59 B. J. Medical College & Civil Hospital Ahmedabad Gujarat India 380016
    60 GMERS Medical College and General Hospital Baroda Gujarat India 390021
    61 M S Ramaiah Medical College and Hospitals Bangalore Karnataka India 560054
    62 Medstar Speciality Hospital Bangalore Karnataka India 560092
    63 BSES MG Hospital Mumbai Maharashtra India 400058
    64 All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra India 441108
    65 Grant Medical Foundation - Ruby Hall Clinic Pune Maharashtra India 411001
    66 Madras Diabetes Research Foundation Chennai Tamil Nadu India 600086
    67 Kumudini Devi Diabetes Research Center Hyderabad Telangana India 500072
    68 Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital Kolkata West Bengal India 700020
    69 Tokuyama Clinic Chiba City Chiba Japan 261-0004
    70 Steel Memorial Yawata Hospital Kitakyushu Fukuoka Japan 805-8508
    71 MinamiAkatsukaClinic Mito Ibaraki Japan 311-4153
    72 Iwamoto Clinic Marugame Kagawa Japan 765-0071
    73 Hayashi Diabetes Internal Medicine Clinic Chigasaki Kanagawa Japan 253-0044
    74 Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa Japan 242-0004
    75 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    76 The Institute of Medical Science, Asahi Life Foundation Chuo-ku Tokyo Japan 103-0002
    77 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    78 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    79 Heishinkai Medical Group ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
    80 Morinaga Ueno Clinic Kumamoto Japan 860-0863
    81 Abe Clinic Oita Japan 870-0039
    82 AMC Nishiumeda Clinic Osaka Japan 530-0001
    83 Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente Guadalajara Jalisco Mexico 44150
    84 Centro de Investigacion Medica Integral Guadalajara Jalisco Mexico 44160
    85 Nucleo Medico la Paz Guadalajara Jalisco Mexico 44860
    86 Centro de Investigacion Medica de Occidente, S.C. Zapopan Jalisco Mexico 44260
    87 Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Chihuahua Mexico 31110
    88 PanAmerican Clinical Research - Querétaro - Avenida Antea Querétaro Mexico 76100
    89 Instituto Veracruzano en Investigación Clínica S.C. Veracruz Mexico 91851
    90 FAICIC S. de R.L. de C.V. Veracruz Mexico 91900
    91 Puerto Rico Health Institute Dorado Puerto Rico 00646
    92 Advance Medical Research Center San Juan Puerto Rico 00926

    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:
    NCT05971940
    Other Study ID Numbers:
    • 18564
    • J2A-MC-GZGT
    • U1111-1290-5157
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 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 Aug 2, 2023