Back to resultsA Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Orforglipron
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- Syed Research Consultants LlcRecruiting
- Aventiv ResearchRecruiting
- Epic Medical Research - SurpriseRecruiting
- Quality of Life Medical & Research CenterRecruiting
- Neighborhood Healthcare Institute of HealthRecruiting
- National Research Institute - Huntington ParkRecruiting
- Ark Clinical ResearchRecruiting
- National Research Institute - WilshireRecruiting
- Infinity Clinical Research - NorcoRecruiting
- Norcal Endocrinology & Internal MedicineRecruiting
- Connecticut Clinical Research - CromwellRecruiting
- Invictus Clinical Research GroupRecruiting
- Hillcrest Medical ResearchRecruiting
- K2 Medical ResearchRecruiting
- Global Health Research Center, Inc.Recruiting
- West Orange EndocrinologyRecruiting
- Clinical Research AtlantaRecruiting
- Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
- Family First Medical CenterRecruiting
- American Health Network of IN, LLC
- Tekton Research - WichitaRecruiting
- Alliance for Multispecialty Research, LLCRecruiting
- Revival Research Institute - DearbornRecruiting
- Billings ClinicRecruiting
- Ellipsis Research GroupRecruiting
- Central New York Clinical ResearchRecruiting
- Monroe Biomedical ResearchRecruiting
- Lucas Research - New BernRecruiting
- Alliance for Multispecialty Research, LLCRecruiting
- The Corvallis Clinic, P.C.Recruiting
- Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairRecruiting
- Preferred Primary Care PhysiciansRecruiting
- The Research Center of The UpstateRecruiting
- MDFirst Research, LLCRecruiting
- The Jackson ClinicRecruiting
- Dallas Diabetes Research CenterRecruiting
- Endocrine Ips, PllcRecruiting
- Amir A Hassan, MD, PARecruiting
- Burke Internal Medicine and ResearchRecruiting
- Wannan Medical College Yijishan Hospital
- Luhe Hospital
- Beijing Pinggu District Hospital
- Huizhou Municipal Central Hospital
- Nanyang First People's HospitalRecruiting
- The Second Affiliated Hospital of Zhengzhou University
- Nanjing First Hospital
- The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
- Dalian Municipal Central Hospital Affiliated of Dalian Medical University
- Jinan Central Hospital
- Pudong New Area People's Hospital Shanghai
- West China Hospital of Sichuan University
- B. J. Medical College & Civil Hospital
- GMERS Medical College and General Hospital
- M S Ramaiah Medical College and Hospitals
- Medstar Speciality Hospital
- BSES MG Hospital
- All India Institute of Medical Sciences (AIIMS) - Nagpur
- Grant Medical Foundation - Ruby Hall Clinic
- Madras Diabetes Research Foundation
- Kumudini Devi Diabetes Research Center
- Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
- Tokuyama ClinicRecruiting
- Steel Memorial Yawata HospitalRecruiting
- Hasegawa Medical Clinic
- MinamiAkatsukaClinicRecruiting
- Iwamoto Internal Medicine ClinicRecruiting
- Hayashi Diabetes Internal Medicine ClinicRecruiting
- Medical Corporation Yuga Tsuruma Kaneshiro Diabetes ClinicRecruiting
- Medical Corporation Heishinkai OCROM ClinicRecruiting
- The Institute for Adult Disease, Asahi Life FoundationRecruiting
- Tokyo-Eki Center-building ClinicRecruiting
- Fukuwa ClinicRecruiting
- Heishinkai Medical Group ToCROM ClinicRecruiting
- Morinaga Ueno ClinicRecruiting
- Abe ClinicRecruiting
- Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
- Centro de Investigacion Medica Integral
- Salud Cardiovascular
- Centro de Investigacion Medica de Occidente, S.C.
- Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
- PanAmerican Clinical Research - Querétaro - Avenida Antea
- Instituto Veracruzano en Investigación Clínica S.C.
- FAICIC S. de R.L. de C.V.
- Puerto Rico Health InstituteRecruiting
- Advance Medical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Orforglipron Dose 1
Orforglipron Dose 2
Orforglipron Dose 3
Placebo
Arm Description
Participants will receive orforglipron orally.
Participants will receive orforglipron orally.
Participants will receive orforglipron orally.
Participants will receive placebo orally.
Outcomes
Primary Outcome Measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary Outcome Measures
Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
Change from Baseline in Fasting Serum Glucose
Percentage Change from Baseline in Body Weight
Change from Baseline in Body Weight
Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
Change from Baseline in Systolic Blood Pressure (SBP)
Change from Baseline in Non-HDL Cholesterol
Percentage Change from Baseline in Triglycerides
Percentage of Participants Who Achieved Weight Loss of ≥5%
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05971940
Brief Title
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Acronym
ACHIEVE-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
April 9, 2025 (Anticipated)
Study Completion Date
April 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orforglipron Dose 1
Arm Type
Experimental
Arm Description
Participants will receive orforglipron orally.
Arm Title
Orforglipron Dose 2
Arm Type
Experimental
Arm Description
Participants will receive orforglipron orally.
Arm Title
Orforglipron Dose 3
Arm Type
Experimental
Arm Description
Participants will receive orforglipron orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo orally.
Intervention Type
Drug
Intervention Name(s)
Orforglipron
Other Intervention Name(s)
LY3502970
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 40
Secondary Outcome Measure Information:
Title
Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
Time Frame
Week 40
Title
Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
Time Frame
Week 40
Title
Change from Baseline in Fasting Serum Glucose
Time Frame
Baseline, Week 40
Title
Percentage Change from Baseline in Body Weight
Time Frame
Baseline, Week 40
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 40
Title
Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
Time Frame
Baseline, Week 40
Title
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Week 40
Title
Change from Baseline in Non-HDL Cholesterol
Time Frame
Baseline, Week 40
Title
Percentage Change from Baseline in Triglycerides
Time Frame
Baseline, Week 40
Title
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time Frame
Week 40
Title
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
Time Frame
Baseline, Week 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Syed Research Consultants Llc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
256-383-4473
First Name & Middle Initial & Last Name & Degree
AARON W KARR
Facility Name
Aventiv Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
614-336-7880
First Name & Middle Initial & Last Name & Degree
Roy C St. John
Facility Name
Epic Medical Research - Surprise
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85378
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Greatwood
Facility Name
Quality of Life Medical & Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
520-731-2333
First Name & Middle Initial & Last Name & Degree
Walter S. Patton
Facility Name
Neighborhood Healthcare Institute of Health
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
760-737-6984
First Name & Middle Initial & Last Name & Degree
James H Schultz
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
323-588-1990
First Name & Middle Initial & Last Name & Degree
Stanley H. Hsia
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha G Navarro
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
213-483-1800
First Name & Middle Initial & Last Name & Degree
David Guzman
Facility Name
Infinity Clinical Research - Norco
City
Norco
State/Province
California
ZIP/Postal Code
92860
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
714-252-6689
First Name & Middle Initial & Last Name & Degree
Peter Mattar
Facility Name
Norcal Endocrinology & Internal Medicine
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
925-552-5280
First Name & Middle Initial & Last Name & Degree
Yshay Shlesinger
Facility Name
Connecticut Clinical Research - Cromwell
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8606320144
First Name & Middle Initial & Last Name & Degree
Charles Brendan Montano
Facility Name
Invictus Clinical Research Group
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-842-6434
First Name & Middle Initial & Last Name & Degree
Juan F Zapata
Facility Name
Hillcrest Medical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
386-999-7616
First Name & Middle Initial & Last Name & Degree
John M Hill
Facility Name
K2 Medical Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-810-2790
First Name & Middle Initial & Last Name & Degree
Neel Patel
Facility Name
Global Health Research Center, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-824-0026
First Name & Middle Initial & Last Name & Degree
Maray Rocher
Facility Name
West Orange Endocrinology
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
4074804830
First Name & Middle Initial & Last Name & Degree
Jose Manuel Mandry
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deon Miller
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
470-317-3604
First Name & Middle Initial & Last Name & Degree
Dwight Blake
Facility Name
Family First Medical Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2085527700
First Name & Middle Initial & Last Name & Degree
Flint Rudd Packer
Facility Name
American Health Network of IN, LLC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan David Condit
Facility Name
Tekton Research - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Alleman
Facility Name
Alliance for Multispecialty Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert J Noveck
Facility Name
Revival Research Institute - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulhassan Saad
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
406-435-8470
First Name & Middle Initial & Last Name & Degree
Lauren Kleess
Facility Name
Ellipsis Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
718-499-6099
First Name & Middle Initial & Last Name & Degree
Jorge Serje
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
315-682-3263
First Name & Middle Initial & Last Name & Degree
Jon Christopher Stringer
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awawu Igbinadolor
Facility Name
Lucas Research - New Bern
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2522225700
First Name & Middle Initial & Last Name & Degree
Claire Ann Presswood
Facility Name
Alliance for Multispecialty Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
405-701-8999
First Name & Middle Initial & Last Name & Degree
Lisa Connery
Facility Name
The Corvallis Clinic, P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Hopson
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
412-942-0023
First Name & Middle Initial & Last Name & Degree
Raman S Purighalla
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
724-912-0033
First Name & Middle Initial & Last Name & Degree
Paul A. Hartley
Facility Name
The Research Center of The Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
864-626-3117
First Name & Middle Initial & Last Name & Degree
Harlicia Farley
Facility Name
MDFirst Research, LLC
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
704-491-1102
First Name & Middle Initial & Last Name & Degree
AMRENDRA KUMAR
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
731-660-8396
First Name & Middle Initial & Last Name & Degree
Kellie Wallace-Wilding
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-566-7799
First Name & Middle Initial & Last Name & Degree
Dan Lender
Facility Name
Endocrine Ips, Pllc
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-973-3415
First Name & Middle Initial & Last Name & Degree
Amer S Al-Karadsheh
Facility Name
Amir A Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2819443610
First Name & Middle Initial & Last Name & Degree
Amir Ali Hassan, MD
Facility Name
Burke Internal Medicine and Research
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
703-455-9711
First Name & Middle Initial & Last Name & Degree
Nashwa Gabra
Facility Name
Wannan Medical College Yijishan Hospital
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
18355335266
First Name & Middle Initial & Last Name & Degree
Jialin Gao
Facility Name
Luhe Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0106954390169
First Name & Middle Initial & Last Name & Degree
Dong Zhao
Facility Name
Beijing Pinggu District Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
13911080328
First Name & Middle Initial & Last Name & Degree
yufeng li
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Li
Facility Name
Nanyang First People's Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihua Wang
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
15838123695
First Name & Middle Initial & Last Name & Degree
Qingju Li
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18951762690
First Name & Middle Initial & Last Name & Degree
Yibing Lu
Facility Name
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116033
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
041184412001
First Name & Middle Initial & Last Name & Degree
Xinyu Li
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
15318816218
First Name & Middle Initial & Last Name & Degree
Xiaolin Dong
Facility Name
Pudong New Area People's Hospital Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhen JIANG
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
18980601658
First Name & Middle Initial & Last Name & Degree
Huiwen Tan
Facility Name
B. J. Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
919924643799
First Name & Middle Initial & Last Name & Degree
Kartikeya Parmar
Facility Name
GMERS Medical College and General Hospital
City
Baroda
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
912652772799
First Name & Middle Initial & Last Name & Degree
Meenakshi Shah
Facility Name
M S Ramaiah Medical College and Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
918197132111
First Name & Middle Initial & Last Name & Degree
Dr Chitra Selvan
Facility Name
Medstar Speciality Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
09884457106
First Name & Middle Initial & Last Name & Degree
ambrish c
Facility Name
BSES MG Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400058
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MANOJ CHAWLA
Facility Name
All India Institute of Medical Sciences (AIIMS) - Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
441108
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9930805548
First Name & Middle Initial & Last Name & Degree
Udit Narang
Facility Name
Grant Medical Foundation - Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9822091220
First Name & Middle Initial & Last Name & Degree
Sanjay Chunilal Agarwal
Facility Name
Madras Diabetes Research Foundation
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9840134505
First Name & Middle Initial & Last Name & Degree
VISWANATHAN MOHAN
Facility Name
Kumudini Devi Diabetes Research Center
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500072
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
917842041355
First Name & Middle Initial & Last Name & Degree
Vishnupriya Rao Paturi
Facility Name
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujoy Ghosh
Facility Name
Tokuyama Clinic
City
Mihama-ku,Chiba City
State/Province
Chiba
ZIP/Postal Code
261-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81432396539
First Name & Middle Initial & Last Name & Degree
Takahiko Tokuyama
Facility Name
Steel Memorial Yawata Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udai Nakamura
Facility Name
Hasegawa Medical Clinic
City
Chitose
State/Province
Hokkaido
ZIP/Postal Code
066-0032
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Hasegawa
Facility Name
MinamiAkatsukaClinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4153
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81292576060
First Name & Middle Initial & Last Name & Degree
Hideo Takahashi
Facility Name
Iwamoto Internal Medicine Clinic
City
Zentsuji
State/Province
Kagawa
ZIP/Postal Code
765-0071
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiro Iwamoto
Facility Name
Hayashi Diabetes Internal Medicine Clinic
City
Chigasaki
State/Province
Kanagawa
ZIP/Postal Code
253-0044
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsutomu Hayashi
Facility Name
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
City
Yamato-shi
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81462717410
First Name & Middle Initial & Last Name & Degree
Taro Asakura
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0663308810
First Name & Middle Initial & Last Name & Degree
Satoshi Inoue
Facility Name
The Institute for Adult Disease, Asahi Life Foundation
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0002
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukiko Onishi
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arihiro Kiyosue
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81362623751
First Name & Middle Initial & Last Name & Degree
Yasushi Fukushima
Facility Name
Heishinkai Medical Group ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osamu Matsuoka
Facility Name
Morinaga Ueno Clinic
City
Kumamoto
ZIP/Postal Code
860-0863
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
810963460111
First Name & Middle Initial & Last Name & Degree
Hiroshi Morinaga
Facility Name
Abe Clinic
City
Oita
ZIP/Postal Code
870-0039
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsushige Abe
Facility Name
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maricela Vidrio
Facility Name
Centro de Investigacion Medica Integral
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
523311070722
First Name & Middle Initial & Last Name & Degree
Carlos Alejandro Stobschinski de Alba
Facility Name
Salud Cardiovascular
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44860
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
5213336392861
First Name & Middle Initial & Last Name & Degree
Agustin Lopez
Facility Name
Centro de Investigacion Medica de Occidente, S.C.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
44260
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
523312044280
First Name & Middle Initial & Last Name & Degree
Emilia Susana Pelayo Orozco
Facility Name
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
City
Chihuahua
ZIP/Postal Code
31110
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
526144398618
First Name & Middle Initial & Last Name & Degree
Luis Alejandro Nevarez
Facility Name
PanAmerican Clinical Research - Querétaro - Avenida Antea
City
Querétaro
ZIP/Postal Code
76100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
524422502985
First Name & Middle Initial & Last Name & Degree
Juan Villagordoa Mesa
Facility Name
Instituto Veracruzano en Investigación Clínica S.C.
City
Veracruz
ZIP/Postal Code
91851
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
2299323157
First Name & Middle Initial & Last Name & Degree
Rosa Isela Luna Ceballos
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
522299327808
First Name & Middle Initial & Last Name & Degree
Alejandro Quintin Barrat Hernandez
Facility Name
Puerto Rico Health Institute
City
Dorado
ZIP/Postal Code
00646
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7877961049
First Name & Middle Initial & Last Name & Degree
Elham Shana Ghorbani
Facility Name
Advance Medical Research Center
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
5208410241
First Name & Middle Initial & Last Name & Degree
Orvil F. Martinez Rivera
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/413375
Description
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)
Learn more about this trial
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
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