ACHIEVE-4: A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05803421
Collaborator
(none)
2,620
321
2
29.7
8.2
0.3
Study Details
Study Description
Brief Summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2620 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
Actual Study Start Date
:
Apr 3, 2023
Anticipated Primary Completion Date
:
Jan 24, 2025
Anticipated Study Completion Date
:
Sep 24, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Orforglipron Participants will receive escalated doses of orforglipron orally. |
Drug: Orforglipron
Administered orally once daily
Other Names:
|
| Active Comparator: Insulin Glargine Participants will receive insulin glargine subcutaneously (SC). Doses will be individualized and titrated according to a treat-to-target algorithm. |
Drug: Insulin Glargine
Administered SC once daily
|
Outcome Measures
Primary Outcome Measures
- Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death] [Baseline to End of the Study (Approximate Maximum 104 Weeks)]
Time to First Occurrence of Any MACE-4 (Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular [CV] Death)
Secondary Outcome Measures
- Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death) [Baseline to End of the Study (Approximately 104 Weeks)]
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
- Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 52]
Change from Baseline in HbA1c
- Change from Baseline in Fasting Serum Glucose [Baseline, Week 52]
Change from Baseline in Fasting Serum Glucose
- Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile [Baseline, Week 52]
Change from Baseline in Daily Average 7-point SMBG
- Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol) [Week 52]
Percentage of Participants with HbA1c Target Values <7.0% (53 mmol/mol)
- Change from Baseline in Body Weight [Baseline, Week 52]
Change from Baseline in Body Weight
- Percent Change from Baseline Body Weight [Week 52]
Percent Change from Baseline Body Weight
- Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score [Baseline, Week 52]
The SF-36v2 acute form is a 36-item generic, participant completed measure designed to assess 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores of each domain are measured by T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health.
- Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron [Baseline through Week 52]
PK will be estimated based on the population PK model.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have been diagnosed with type 2 diabetes mellitus (T2DM)
-
Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
-
Have HbA1c at screening
-
≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
-
≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
-
Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
-
Have increased risk for cardiovascular (CV) events due to:
-
Coronary heart disease
-
Peripheral arterial disease, presumed to be of atherosclerotic origin
-
Cerebrovascular disease, presumed to be of atherosclerotic origin
-
Chronic kidney disease (CKD)
-
Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
-
Are of stable weight (± 5%) for at least 90 days prior to screening
-
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria:
-
Have type 1 diabetes mellitus
-
Have had chronic or acute pancreatitis any time prior to screening
-
Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
-
Have a known clinically significant gastric emptying abnormality
-
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
-
Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
-
Have an eGFR <15 mL/min/1.73 m2 as determined at screening
-
Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
-
Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
-
Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Avalon Medical Group | Muscle Shoals | Alabama | United States | 35661 |
| 2 | Cahaba Research - Pelham | Pelham | Alabama | United States | 35124 |
| 3 | Syed Research Consultants Llc | Sheffield | Alabama | United States | 35660 |
| 4 | Aventiv Research | Mesa | Arizona | United States | 85206 |
| 5 | Elite Clinical Studies, LLC | Phoenix | Arizona | United States | 85018 |
| 6 | Absolute Clinical Research | Phoenix | Arizona | United States | 85051 |
| 7 | Clinical Research Institute of Arizona (CRI) - Sun City West | Sun City West | Arizona | United States | 85375 |
| 8 | Alliance for Multispecialty Research - Clinical Research Consortium | Tempe | Arizona | United States | 47714 |
| 9 | KLR Business Group, Inc. dba Arkansas Clinical Research | Little Rock | Arkansas | United States | 72205 |
| 10 | Medical Investigations | Little Rock | Arkansas | United States | 72211 |
| 11 | Valley Clinical Trials, Inc. | Covina | California | United States | 91723 |
| 12 | Neighborhood Healthcare Institute of Health | Escondido | California | United States | 92025 |
| 13 | Valley Research | Fresno | California | United States | 93720 |
| 14 | NorCal Medical Research, Inc | Greenbrae | California | United States | 94904 |
| 15 | UCSD - Altman Clinical and Translational Research Institute (ACTRI) | La Jolla | California | United States | 92037 |
| 16 | Pacific Clinical Studies | Los Alamitos | California | United States | 90720 |
| 17 | Velocity Clinical Research, Westlake | Los Angeles | California | United States | 90057 |
| 18 | Riverside University Health System - Medical Center | Moreno Valley | California | United States | 92555 |
| 19 | Velocity Clinical Research, North Hollywood | North Hollywood | California | United States | 91606 |
| 20 | Valley Clinical Trials, Inc. | Northridge | California | United States | 91325 |
| 21 | Pasadena Clinical Research | Pasadena | California | United States | 91105 |
| 22 | LCGK Research | San Carlos | California | United States | 94070 |
| 23 | Norcal Endocrinology & Internal Medicine | San Ramon | California | United States | 94583 |
| 24 | Millennium Clinical Trials | Thousand Oaks | California | United States | 91360 |
| 25 | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | United States | 90502 |
| 26 | Rocky Mountain Regional VA Medical Center | Aurora | Colorado | United States | 80045 |
| 27 | University of Colorado Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
| 28 | Legacy Clinical Trials | Colorado Springs | Colorado | United States | 80909 |
| 29 | CMR of Greater New Haven, LLC | Hamden | Connecticut | United States | 06517 |
| 30 | Orlando Heart & Vascular Institute | Altamonte Springs | Florida | United States | 32714 |
| 31 | Excel Medical Clinical Trials | Boca Raton | Florida | United States | 33434 |
| 32 | Thor Clinical Research | Brandon | Florida | United States | 33511 |
| 33 | Velocity Clinical Research, New Smyrna Beach | Edgewater | Florida | United States | 32132 |
| 34 | Alliance for Multispecialty Research, LLC | Fort Myers | Florida | United States | 33912 |
| 35 | Northeast Research Institute - Downtown Office | Jacksonville | Florida | United States | 32204 |
| 36 | Panax Clinical Research | Miami Lakes | Florida | United States | 33014 |
| 37 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
| 38 | West Orange Endocrinology | Ocoee | Florida | United States | 34761 |
| 39 | Peace River Cardiovascular Center | Port Charlotte | Florida | United States | 33952 |
| 40 | Precision Research Center | Tampa | Florida | United States | 33614 |
| 41 | Metabolic Research Institute, Inc. | West Palm Beach | Florida | United States | 33401 |
| 42 | Encore Medical Research - Weston | Weston | Florida | United States | 33331 |
| 43 | Clinical Research of Central Florida | Winter Haven | Florida | United States | 33880 |
| 44 | Conquest Research | Winter Park | Florida | United States | 32789 |
| 45 | Physicians Research Associates | Lawrenceville | Georgia | United States | 30045 |
| 46 | Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia | United States | 30046 |
| 47 | East Coast Institute for Research, LLC | Macon | Georgia | United States | 31210 |
| 48 | SKY Clinical Research Network Group-Blake | Union City | Georgia | United States | 30291 |
| 49 | North Georgia Clinical Research | Woodstock | Georgia | United States | 30189 |
| 50 | Elite Clinical Trials | Blackfoot | Idaho | United States | 83221 |
| 51 | Saltzer Health | Nampa | Idaho | United States | 83686 |
| 52 | Elite Clinical Trials | Rexburg | Idaho | United States | 83440 |
| 53 | Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | United States | 60640 |
| 54 | Clinical Investigation Specialists | Gurnee | Illinois | United States | 60031 |
| 55 | Great Lakes Clinical Trials - Gurnee | Gurnee | Illinois | United States | 60031 |
| 56 | American Health Network of Indiana, LLC - Avon | Avon | Indiana | United States | 46123 |
| 57 | Qualmedica Research, LLC | Evansville | Indiana | United States | 47715 |
| 58 | American Health Network of Indiana, LLC - Franklin | Franklin | Indiana | United States | 46131 |
| 59 | American Health Network of Indiana, LLC - Greenfield | Greenfield | Indiana | United States | 46140 |
| 60 | American Health Network of Indiana, LLC - Muncie | Muncie | Indiana | United States | 47304 |
| 61 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 62 | Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | United States | 50265 |
| 63 | Alliance for Multispecialty Research, LLC | El Dorado | Kansas | United States | 67042 |
| 64 | Alliance for Multispecialty Research, LLC | Newton | Kansas | United States | 67114 |
| 65 | Cotton O'Neil Clinical Research Center | Topeka | Kansas | United States | 66606 |
| 66 | Cotton O'Neil Clinical Research Center | Topeka | Kansas | United States | 66606 |
| 67 | Qualmedica Research | Bowling Green | Kentucky | United States | 42101 |
| 68 | L-MARC Research Center | Louisville | Kentucky | United States | 40213 |
| 69 | Louisiana Heart Center - Hammond | Hammond | Louisiana | United States | 70403 |
| 70 | Care Access - Lake Charles | Lake Charles | Louisiana | United States | 70601 |
| 71 | Maryland Cardiovascular Specialists | Baltimore | Maryland | United States | 21229 |
| 72 | Endocrine and Metabolic Consultants | Rockville | Maryland | United States | 20852 |
| 73 | ActivMed Practices and Research | Methuen | Massachusetts | United States | 01844 |
| 74 | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | United States | 48098 |
| 75 | SKY Clinical Research Network Group - Hall | Fayette | Mississippi | United States | 39069 |
| 76 | SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | United States | 39157 |
| 77 | Clinical Research Professionals | Chesterfield | Missouri | United States | 63005 |
| 78 | Diabetes and Endocrinology Specialists | Chesterfield | Missouri | United States | 63017 |
| 79 | StudyMetrix Research | Saint Peters | Missouri | United States | 63303 |
| 80 | Clinvest Research LLC | Springfield | Missouri | United States | 65807 |
| 81 | Logan Health Research | Kalispell | Montana | United States | 59901 |
| 82 | Las Vegas Medical Research | Las Vegas | Nevada | United States | 89113 |
| 83 | Palm Research Center Tenaya | Las Vegas | Nevada | United States | 89128 |
| 84 | Palm Research Center Sunset | Las Vegas | Nevada | United States | 89148 |
| 85 | Northern Nevada Endocrinology | Reno | Nevada | United States | 89511 |
| 86 | UniMed Center | East Brunswick | New Jersey | United States | 08816 |
| 87 | Albany Stratton VA Medical Center | Albany | New York | United States | 12208 |
| 88 | Meridian Clinical Research, LLC | Binghamton | New York | United States | 13905 |
| 89 | SUNY Downstate Health Sciences University | Brooklyn | New York | United States | 11203 |
| 90 | Velocity Clinical Research, Syracuse | East Syracuse | New York | United States | 13057 |
| 91 | NYC Research INC | Long Island City | New York | United States | 11106 |
| 92 | Mid Hudson Medical Research | New Windsor | New York | United States | 12553 |
| 93 | IMA Clinical Research Manhattan | New York | New York | United States | 10036 |
| 94 | Meridian Clinical Research, LLC | Vestal | New York | United States | 13850 |
| 95 | University of North Carolina Medical Center | Chapel Hill | North Carolina | United States | 27514 |
| 96 | PharmQuest Life Sciences, LLC | Greensboro | North Carolina | United States | 27408 |
| 97 | Lucas Research, Inc | Morehead City | North Carolina | United States | 28557 |
| 98 | Lillestol Research | Fargo | North Dakota | United States | 58104 |
| 99 | Aventiv Research | Dublin | Ohio | United States | 43016 |
| 100 | Tekton Research, Inc | Moore | Oklahoma | United States | 73160 |
| 101 | Central States Research | Tulsa | Oklahoma | United States | 74136 |
| 102 | Tekton Research, Inc | Yukon | Oklahoma | United States | 73099 |
| 103 | Northwest Research Center | Portland | Oregon | United States | 97202 |
| 104 | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | United States | 15009 |
| 105 | Capital Area Research - Newport | Newport | Pennsylvania | United States | 17074 |
| 106 | Clinical Research of Philadelphia | Philadelphia | Pennsylvania | United States | 19114 |
| 107 | Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair | Pittsburgh | Pennsylvania | United States | 15243 |
| 108 | Preferred Primary Care Physicians | Uniontown | Pennsylvania | United States | 15401 |
| 109 | The Research Center of The Upstate | Greenville | South Carolina | United States | 29607 |
| 110 | Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc | Rapid City | South Dakota | United States | 57701 |
| 111 | Texas Diabetes & Endocrinology, P.A. | Austin | Texas | United States | 78749 |
| 112 | South Texas Clinical Research | Corpus Christi | Texas | United States | 78404 |
| 113 | Thyroid, Endocrinology, and Diabetes | Dallas | Texas | United States | 75208 |
| 114 | Velocity Clinical Research, Dallas | Dallas | Texas | United States | 75230 |
| 115 | Cardio Voyage | Denison | Texas | United States | 75020 |
| 116 | Soma Clinical Trials | Denison | Texas | United States | 75020 |
| 117 | Care United Research | Forney | Texas | United States | 75126 |
| 118 | Valley Institute of Research - Fort Worth | Fort Worth | Texas | United States | 76164 |
| 119 | Juno Research | Houston | Texas | United States | 77040 |
| 120 | Biopharma Informatic, LLC | Houston | Texas | United States | 77043 |
| 121 | Endocrine Ips, Pllc | Houston | Texas | United States | 77079 |
| 122 | Amir A Hassan, MD, PA | Houston | Texas | United States | 77089 |
| 123 | Biopharma Informatic, LLC | McAllen | Texas | United States | 78503 |
| 124 | Epic Medical Research | Red Oak | Texas | United States | 75154 |
| 125 | Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas | United States | 78681 |
| 126 | Audie L Murphy VA Hospital | San Antonio | Texas | United States | 78229 |
| 127 | Tekton Research - Fredericksburg Road | San Antonio | Texas | United States | 78229 |
| 128 | VIP Trials | San Antonio | Texas | United States | 78230 |
| 129 | Consano Clinical Research, LLC | Shavano Park | Texas | United States | 78231 |
| 130 | Soma Clinical Trials | Wylie | Texas | United States | 75098 |
| 131 | Advanced Research Institute | Ogden | Utah | United States | 84405 |
| 132 | Chrysalis Clinical Research | Saint George | Utah | United States | 84790 |
| 133 | Wasatch Clinical Research, LLC | Salt Lake City | Utah | United States | 84107 |
| 134 | Kalo Clinical Research | West Valley City | Utah | United States | 84120 |
| 135 | Manassas Clinical Research Center | Manassas | Virginia | United States | 20110 |
| 136 | Virginia Research Center | Midlothian | Virginia | United States | 23114 |
| 137 | Eastern Virginia Medical School (EVMS) Strelitz Diabetes Research Center | Norfolk | Virginia | United States | 23510 |
| 138 | Centricity Research Suffolk Primary Care | Suffolk | Virginia | United States | 23435 |
| 139 | Eastside Research Associates | Redmond | Washington | United States | 98052 |
| 140 | Multicare Institute for Research and Innovation | Spokane | Washington | United States | 99202 |
| 141 | Universal Research Group | Tacoma | Washington | United States | 98405 |
| 142 | Wenatchee Valley Hospital | Wenatchee | Washington | United States | 98801 |
| 143 | Organizacion Medica de Investigacion | Caba | Buenos Aires | Argentina | C1015ABO |
| 144 | Centro Privado de Medicina Familiar / Mindout Research | Ciudad Autónoma de Buenos Aire | Buenos Aires | Argentina | 1417 |
| 145 | Glenny Corp | Buenos Aires | Ciudad Autónoma De Buenos Aire | Argentina | 1430 |
| 146 | CIPREC | Buenos Aires | Ciudad Autónoma De Buenos Aire | Argentina | C1061AAS |
| 147 | Mautalen Salud e Investigación | Buenos Aires | Ciudad Autónoma De Buenos Aire | Argentina | C1128AAF |
| 148 | Polo de Salud Vistalba | Luján de Cuyo | Mendoza | Argentina | 5509 |
| 149 | Centro de Investigaciones Clínicas Baigorria | Granadero Baigorria | Santa Fe | Argentina | 2152 |
| 150 | Instituto Médico Catamarca IMEC | Rosario | Santa Fe | Argentina | 2000 |
| 151 | Investigaciones Clínicas Tucumán | San Miguel de Tucuman | Tucumán | Argentina | 4000 |
| 152 | Buenos Aires Macula S.A | Buenos Aires | Argentina | 1061 | |
| 153 | CEMEDIC | Buenos Aires | Argentina | 1407 | |
| 154 | Cardiología Palermo | Buenos Aires | Argentina | 1425 | |
| 155 | CENUDIAB | Ciudad Autónoma de Buenos Aire | Argentina | C1440AAD | |
| 156 | Hospital San Roque | Córdoba | Argentina | 5000 | |
| 157 | Centro de Investigaciones Clinicas Instituto del Corazon (CICIC) | Córdoba | Argentina | X5002HWE | |
| 158 | Konventhospital der Barmherzigen Brüder Linz | Linz | Oberösterreich | Austria | 4021 |
| 159 | Medizinische Universität Graz | Graz | Steiermark | Austria | 8036 |
| 160 | Medizinische Universitaet Innsbruck | Innsbruck | Tirol | Austria | 6020 |
| 161 | VIVIT | Feldkirch | Vorarlberg | Austria | 6800 |
| 162 | Zentrum für klinische Studien Dr Hanusch Gmbh | Vienna | Wien | Austria | 1060 |
| 163 | Medizinische Universität Wien | Vienna | Wien | Austria | 1090 |
| 164 | Private Practice - Dr. Evelyn Fliesser-Gorzer | Sankt Stefan ob Stainz | Austria | 8511 | |
| 165 | Klinik Landstraße | Wien | Austria | 1030 | |
| 166 | Krankenhaus Hietzing | Wien | Austria | 1130 | |
| 167 | Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE | Fortaleza | Ceará | Brazil | 60160-230 |
| 168 | Centro de Pesquisa Clinica do Brasil | Brasilia | Distrito Federal | Brazil | 71625-175 |
| 169 | CEDOES | Vitória | Espírito Santo | Brazil | 29055450 |
| 170 | Hospital Moinhos de Vento | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-001 |
| 171 | Núcleo de Pesquisa Clínica do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul | Brazil | 90430-001 |
| 172 | Centro de Pesquisa Clinica do Coracao | Aracaju | Sergipe | Brazil | 49055-530 |
| 173 | Loema Instituto de Pesquisa Clinica | Campinas | São Paulo | Brazil | 13010-001 |
| 174 | Instituto de Pesquisa Clínica de Campinas | Campinas | São Paulo | Brazil | 13060-080 |
| 175 | Centro de Pesquisa Sao Lucas | Campinas | São Paulo | Brazil | 13060-803 |
| 176 | Pesquisare Saude | Santo André | São Paulo | Brazil | 09080-110 |
| 177 | CPCLIN | Sao Paulo | São Paulo | Brazil | 01228-200 |
| 178 | ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos | São Paulo | Brazil | 12243-280 |
| 179 | IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | Brazil | 20241-180 | |
| 180 | NotreDame Intermedica Saude S.A | São Paulo | Brazil | 01229-010 | |
| 181 | Hospital 9 De Julho | São Paulo | Brazil | 01409-902 | |
| 182 | Instituto Dante Pazzanese de Cardiology | São Paulo | Brazil | 04012-909 | |
| 183 | BR Trials - Ensaios Clinicos e Consultoria | São Paulo | Brazil | 05003-090 | |
| 184 | EFERTUS healthcare s.r.o. | Brno | Brno-město | Czechia | 635 00 |
| 185 | EDUMED - Broumov | Broumov | Náchod | Czechia | 550 01 |
| 186 | EDUMED - Jaroměř | Jaroměř | Náchod | Czechia | 551 01 |
| 187 | AIDIN VK s.r.o. | Hranice | Olomoucký Kraj | Czechia | 753 01 |
| 188 | Dialine - Interni a diabetologicka ambulance | Pilsen | Plzeň-město | Czechia | 301 00 |
| 189 | Milan Kvapil s.r.o., Diabetologicka ambulance | Praha | Praha 4 | Czechia | 14900 |
| 190 | Nefromed | Prague | Praha 6 | Czechia | 160 00 |
| 191 | MUDr. Barbora Diepoltova | Praha 9 - Klanovice | Praha 9 | Czechia | 190 14 |
| 192 | FLEDIP s.r.o. | Prague | Praha, Hlavní Mešto | Czechia | 160 00 |
| 193 | MUDr. Sabina Palova | Jílové U Prahy | Praha-zápa | Czechia | 25401 |
| 194 | Endokrinologie MUDr. Rehorkova s.r.o. | Hradec Kralove | Czechia | 500 12 | |
| 195 | EDUMED - Náchod | Náchod | Czechia | 547 01 | |
| 196 | PreventaMed | Olomouc | Czechia | 779 00 | |
| 197 | MUDr. Michala Pelikanova s.r.o. | Praha 4 | Czechia | 140 00 | |
| 198 | Nemocnice Cesky Krumlov, a.s. | Český Krumlov | Czechia | 381 01 | |
| 199 | Masarykova Nemocnice V Usti Nad Labem | Rumburk | Ústecký Kraj | Czechia | 40801 |
| 200 | Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel | Hof | Bayern | Germany | 95030 |
| 201 | Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte | Mühldorf | Bayern | Germany | 84453 |
| 202 | Diabetes Zentrum Dr. Tews | Gelnhausen | Hessen | Germany | 63571 |
| 203 | Diabetologische Schwerpunktpraxis Marck Linn Pickel | Pulheim | Hessen | Germany | 35415 |
| 204 | SMO.MD GmbH | Magdeburg | Sachsen-Anhalt | Germany | 39120 |
| 205 | Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut | Leipzig | Sachsen | Germany | 04249 |
| 206 | RED-Institut GmbH | Oldenburg | Schleswig-Holstein | Germany | 23758 |
| 207 | CIMS Studienzentrum Bamberg | Bamberg | Germany | 96049 | |
| 208 | Gemeinschaftspraxis für Diabetologie | Eisenach | Germany | 99817 | |
| 209 | Medic-Center Nürnberg - Schöll & Kollegen | Nürnberg | Germany | 90443 | |
| 210 | Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer null Josef Wenzl | Rehlingen | Germany | 66780 | |
| 211 | Iatriko Paleou Falirou Medical Center | Palaió Fáliro | Attikí (Region) | Greece | 17562 |
| 212 | General Hospital of Athens "G. Gennimatas" | Athens | Attikí | Greece | 11527 |
| 213 | General Hospital of Athens Laiko | Athens | Attikí | Greece | 11527 |
| 214 | Attikon General University Hospital | Chaidari | Attikí | Greece | 12462 |
| 215 | General Hospital of Lamia | Lamia | Fthiótida | Greece | 351 00 |
| 216 | G. Gennimatas General Hospital of Thessaloniki | Thessaloniki | Thessaloníki | Greece | 546 35 |
| 217 | Down Town Hospital | Guwahati | Assam | India | 781006 |
| 218 | Apollo Excelcare Hospital | Guwahati | Assam | India | 781033 |
| 219 | V.S. General Hospital | Ahmedabad | Gujarat | India | 380006 |
| 220 | B. J. Medical College & Civil Hospital | Ahmedabad | Gujarat | India | 380016 |
| 221 | Zydus Hospitals & Healthcare Research Pvt.Ltd. | Ahmedabad | Gujarat | India | 380054 |
| 222 | Nirmal Hospital Pvt Ltd. | Surat | Gujarat | India | 395002 |
| 223 | Victoria Hospital, Bangalore Medical College And Research Institute | Bangalore | Karnataka | India | 560002 |
| 224 | Life Care Hospital and Research Centre | Bangalore | Karnataka | India | 560092 |
| 225 | KLES Dr. Prabhakar Kore Hospital & M.R.C | Belagave | Karnataka | India | 590010 |
| 226 | Karnataka Institute of Medical Sciences | Hubli | Karnataka | India | 580021 |
| 227 | CARE CHL-Hospitals | Indore | Madhya Pradesh | India | 452008 |
| 228 | King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College | Mumbai | Maharashtra | India | 400012 |
| 229 | Central India Cardiology and Research Institute | Nagpur | Maharashtra | India | 440015 |
| 230 | Chellaram Diabetes Institute | Pune | Maharashtra | India | 411021 |
| 231 | S C B Medical College and Hospital | Cuttack | Odisha | India | 753001 |
| 232 | Sawai Man Singh Medical College Hospital (SMS Hospital) | Jaipur | Rajasthan | India | 302004 |
| 233 | Eternal Heart Care Center and Research Institute | Jaipur | Rajasthan | India | 302020 |
| 234 | Università degli Studi Gabriele D' Annunzio | Chieti | Abruzzo | Italy | 66100 |
| 235 | University of Naples Federico II | Naples | Campania | Italy | 80100 |
| 236 | Azienda sanitaria universitaria giuliano isontina ASUGI Ospedale Maggiore- Università di Trieste | Trieste | Friuli-Venezia Giulia | Italy | 34125 |
| 237 | Ospedale Civico Partinico | Partinico | Palermo | Italy | 90047 |
| 238 | Ospedale Le Scotte | Siena | Toscana | Italy | 53100 |
| 239 | AO Santa Maria della Misericordia | Perugia | Umbria | Italy | 06132 |
| 240 | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | Italy | 24127 | |
| 241 | Azienda Ospedaliera Mater Domini | Catanzaro | Italy | 88100 | |
| 242 | Ospedale San Raffaele | Milano | Italy | 20132 | |
| 243 | Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | 28100 | |
| 244 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Roma | Italy | 00168 | |
| 245 | Wonju Severance Christian Hospital | Wonju | Kang-won-do | Korea, Republic of | 26426 |
| 246 | Wonju Severance Christian Hospital | Wonju | Kang-won-do | Korea, Republic of | 26426 |
| 247 | Hanyang University Guri Hospital | Guri-si | Kyǒnggi-do | Korea, Republic of | 11923 |
| 248 | Seoul National University Bundang Hospital | Seongnam | Kyǒnggi-do | Korea, Republic of | 13620 |
| 249 | Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | Korea, Republic of | 42415 |
| 250 | Kangbuk Samsung Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 03181 |
| 251 | Kyung Hee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 05278 |
| 252 | The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 6591 |
| 253 | Severance Hospital, Yonsei University Health System | Seoul | Seoul-teuk | Korea, Republic of | 3722 |
| 254 | Seoul National University Hospital | Seoul | Seoul-teuk | Korea, Republic of | |
| 255 | Ulsan University Hospital | Ulsan | Ulsan-Kwangyǒkshi | Korea, Republic of | 44033 |
| 256 | Clínica San Cosme | Aguascalientes | Aguascalie | Mexico | 20124 |
| 257 | Centro de Investigacion Cardiovascular y Metabólica | Tijuana | Baja California | Mexico | 22500 |
| 258 | Instituto Cardiovascular de León S.C. | León | Guanajuato | Mexico | 37520 |
| 259 | Diseno y Planeacion en Investigacion Medica | Guadalajara | Jalisco | Mexico | 44130 |
| 260 | Private Practice - Dr. Francisco Gerardo Padilla | Guadalajara | Jalisco | Mexico | 44670 |
| 261 | Cardiolink Clin Trials | Monterrey | Nuevo León | Mexico | 64060 |
| 262 | Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. | Culiacán | Sinaloa | Mexico | 80230 |
| 263 | Centro de Estudios de Investigacion Metabolicos y Cardiovasculares | Ciudad Madero | Tamaulipas | Mexico | 89440 |
| 264 | Centro de Investigación Cardiometabólica de Aguascalientes | Aguascalientes | Mexico | 20230 | |
| 265 | Investigacion En Salud Y Metabolismo Sc | Chihuahua | Mexico | 31217 | |
| 266 | Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia | Durango | Mexico | 34000 | |
| 267 | Centro de Estudios Clínicos de Querétaro (CECLIQ) | Querétaro | Mexico | 76000 | |
| 268 | Manati Center for Clinical Research | Manati | Puerto Rico | 00674 | |
| 269 | Puerto Rico Medical Research | Ponce | Puerto Rico | 00717 | |
| 270 | Research and Cardiovascular Corp. | Ponce | Puerto Rico | 00717 | |
| 271 | Mindful Medical Research | San Juan | Puerto Rico | 00918 | |
| 272 | Mgcendo Llc | San Juan | Puerto Rico | 00921 | |
| 273 | GCM Medical Group, PSC - Hato Rey Site | San Juan | Puerto Rico | 917 | |
| 274 | Wellness clinical Research Vega Baja | Vega Baja | Puerto Rico | 00694 | |
| 275 | Diabdana | Oradea | Bihor | Romania | 410147 |
| 276 | Centrul Medical Grandmed | Oradea | Bihor | Romania | 410159 |
| 277 | Mariodiab Clinic | Brasov | Brașov | Romania | 500097 |
| 278 | C.M.D.T.A. Neomed | Brasov | Brașov | Romania | 500283 |
| 279 | Nicodiab | Bucharest | București | Romania | 010507 |
| 280 | Geea Medical Easy Diet | Bucharest | București | Romania | 010627 |
| 281 | Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului | Bucharest | București | Romania | 011053 |
| 282 | Centrul Medical NutriLife | Bucharest | București | Romania | 013761 |
| 283 | Centrul Medical Endocrinologie si Diabet Dr. Paveliu | Bucharest | București | Romania | 50538 |
| 284 | Centrul Medical Mediab | Târgu-Mureș | Mureș | Romania | 540142 |
| 285 | Diabmed Dr. Popescu Alexandrina | Ploiești | Prahova | Romania | 100169 |
| 286 | Cabinet Medical Dr.Geru | Timisoara | Timiș | Romania | 300288 |
| 287 | CMI Dr.Pletea Noemi SRL | Bacău | Romania | 600154 | |
| 288 | SC Minimed SRL | Bacău | Romania | 600238 | |
| 289 | Milena Sante | Galați | Romania | 800001 | |
| 290 | Diamed Obesity | Galați | Romania | 800291 | |
| 291 | Centrul Medical Consultmed | Iași | Romania | 700547 | |
| 292 | Clinica Korall | Satu Mare | Romania | 440055 | |
| 293 | IN-DIA | Lučenec | Banskobystrický Kraj | Slovakia | 984 01 |
| 294 | Metabol KLINIK | Bratislava | Bratislavský Kraj | Slovakia | 811 08 |
| 295 | Diacrin s.r.o. | Bratislava | Bratislavský Kraj | Slovakia | 841 02 |
| 296 | MediVet s.r.o. | Malacky | Bratislavský Kraj | Slovakia | 901 01 |
| 297 | Human Care s.r.o. | Kosice | Košický Kraj | Slovakia | 04001 |
| 298 | Tatratrial s.r.o. | Rožňava | Košický Kraj | Slovakia | 04801 |
| 299 | Areteus s.r.o. | Trebisov | Košický Kraj | Slovakia | 075 01 |
| 300 | MEDI-DIA s.r.o. | Sabinov | Prešovský Kraj | Slovakia | 083 01 |
| 301 | DIA-MED CENTRUM s.r.o. | Puchov | Trenčiansky Kraj | Slovakia | 020 01 |
| 302 | JAL | Trnava | Trnavský Kraj | Slovakia | 917 01 |
| 303 | Diab - Int | Bytca | Žilinský Kraj | Slovakia | 014 01 |
| 304 | NEDÚ - Národný endokrinologický a diabetologický ústav n.o. | Lubochna | Žilinský Kraj | Slovakia | 034 91 |
| 305 | CHUAC-Complejo Hospitalario Universitario A Coruña | A Coruña | A Coruña [La Coruña] | Spain | 15006 |
| 306 | Hu Reina Sofia | Cordoba | Andalucía | Spain | 14004 |
| 307 | Complejo Hospitalario Ruber Juan Bravo | Madrid | Madrid, Comunidad De | Spain | 28006 |
| 308 | Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | Spain | 28223 |
| 309 | Vithas Hospital Sevilla | Seville | Sevilla | Spain | 41950 |
| 310 | Hospital Universitario de La Ribera | Alzira | Valenciana, Comunitat | Spain | 46600 |
| 311 | Hospital General de Segovia | Segovia | Spain | 40002 | |
| 312 | Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Sevilla | Spain | 41003 | |
| 313 | Hospital Universitario Virgen Del Rocio | Sevilla | Spain | 41013 | |
| 314 | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi | Kadikoy | İstanbul | Turkey | 34722 |
| 315 | Baskent University Dr. Turgut Noyan Research and Training Center | Adana | Turkey | 1230 | |
| 316 | Ankara Universitesi Tip Fakultesi Hastanesi | Ankara | Turkey | 06230 | |
| 317 | Aydın Adnan Menderes Universitesi Hastanesi | Aydin | Turkey | 09100 | |
| 318 | Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre | Denizli | Turkey | ||
| 319 | Dicle Üniversitesi | Diyarbakir | Turkey | 21100 | |
| 320 | Erciyes Universitesi Tıp Fakultesi Hastaneleri | Kayseri | Turkey | 38030 | |
| 321 | İnönü Üniversitesi Turgut Özal Tıp Merkezi | Malatya | Turkey | 44280 |
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
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05803421
Other Study ID Numbers:
- 18563
- J2A-MC-GZGS
- 2022-502833-25-00
- U1111-1285-6821
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 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
Additional relevant MeSH terms: