Phase
Condition
Diabetes Mellitus, Type 2
Obesity
Diabetes Prevention
Treatment
RO7795068
Placebo
Enicepatide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability and willingness to self-administer the study drug (or receive an injectionfrom a trained individual if visually impaired or with physical limitations)
Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification orother locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratorytest at screening, and on stable oral therapy for at least 3 months prior toscreening (if applicable). T2DM may be treated with diet/exercise alone or any oralanti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
Body mass index (BMI) ≥27.0 kg/m^2
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion
Exclusion Criteria:
History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosisor history of hyperosmolar state/coma within 12 months prior to screening
Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemiaunawareness within the 6 months prior to screening
At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2non-consecutive days) during screening
Self-reported change in body weight >5 kg within 3 months prior to screening
Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) ordiagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptordeficiency or Prader-Willi syndrome)
Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty ifperformed more than 1 year prior to screening is allowed.
Known clinically significant gastric emptying abnormality (e.g., severegastroparesis or gastric outlet obstruction)
Poorly controlled hypertension at screening
Have any of the following cardiovascular conditions within 3 months prior toscreening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transientischemic attack; Unstable angina; Hospitalization due to congestive heart failure
Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptortriple agonist) within 6 months prior to randomization
Study Design
Connect with a study center
CEDIC Centro de Investigaciones Clinicas
Buenos Aires, C1060ABN
ArgentinaActive - Recruiting
CINME
Buenos Aires, C1056ABI
ArgentinaActive - Recruiting
Centro Medico Viamonte SRL
Buenos Aires, C1120AAC
ArgentinaActive - Recruiting
IME - Instituto Médico Especializado
Buenos Aires, C1405BCH
ArgentinaActive - Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, C1425AGC
ArgentinaActive - Recruiting
Instituto centenario
Ciudad Autonoma Buenos Aires, C1204AAD
ArgentinaActive - Recruiting
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK
ArgentinaActive - Recruiting
Paratus Clinical Western Sydney
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Logan Hospital
Meadowbrook, Queensland 4131
AustraliaActive - Recruiting
Southern Adelaide Diabetes and Endocrine Services (SADES)
Oaklands Park, South Australia 5046
AustraliaActive - Recruiting
Baker Heart and Diabetes Insitute
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Centricity Research Calgary Endocrinology
Calgary, Alberta T2H 2G4
CanadaActive - Recruiting
Dr TG Elliott Inc
Vancouver, British Columbia V5Y 3W2
CanadaActive - Recruiting
TGElliott Inc. dba BC Diabetes
Vancouver, British Columbia V5Y 3W2
CanadaActive - Recruiting
Centricity Research Brampton Endocrinology
Brampton, Ontario L6S 0C6
CanadaActive - Recruiting
Medicor Research Inc
Greater Sudbury, Ontario P3C 1X3
CanadaActive - Recruiting
LMC Clinical Research Inc
Toronto, Ontario M4G 3E8
CanadaActive - Recruiting
Diex Recherche Sherbrooke
Sherbrooke, Quebec J1L 0H8
CanadaActive - Recruiting
Clinique des maladies lipidiques de Quebec
Québec, G1V 4W2
CanadaActive - Recruiting
Yan'an University Xianyang Hospital
Xianyang, Shaanxi 712000
ChinaActive - Recruiting
Beijing Pinggu Hospital
Beijing, 101200
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, 100044
ChinaActive - Recruiting
The Second People's Hospital of Hefei
Hefei, 230011
ChinaActive - Recruiting
Huizhou Central People's Hospital
Huizhou, 516001
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210003
ChinaActive - Recruiting
Shanghai Fifth People's Hospital Affiliated to Fudan University
Shanghai, 201304
ChinaActive - Recruiting
Shanghai Pudong New Area People's Hospital
Shanghai, 201299
ChinaActive - Recruiting
TreDia s.r.o.;Diabetologická ambulance Praha 9
Praha 9 - Klánovice, 19014
CzechiaActive - Recruiting
Hopital de la Conception
Marseille, 13000
FranceActive - Recruiting
CHU de Nice
Nice, 06602
FranceActive - Recruiting
European Hospital Georges Pompidou (HEGP)
Paris, 75908
FranceActive - Recruiting
Chu De Tours
Tours, 37000
FranceActive - Recruiting
InnoDiab Forschung GmbH
Essen, 45136
GermanyActive - Recruiting
Medizentrum Essen Borbeck
Essen, 45355
GermanyActive - Recruiting
Unterfrintroper Hausarztzentrum
Essen, 45359
GermanyActive - Recruiting
Diabeteszentrum Hamburg West
Hamburg, 22607
GermanyActive - Recruiting
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
Hof, 95030
GermanyActive - Recruiting
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung
Pirna, 01796
GermanyActive - Recruiting
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna 40138
ItalyActive - Recruiting
Policlinico Universitario Agostino Gemelli
Rome, Lazio 00168
ItalyActive - Recruiting
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio 00161
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily 90127
ItalyActive - Recruiting
Universita Degli Studi Di Perugia
Perugia, Umbria 06129
ItalyActive - Recruiting
Kasugai Municipal Hospital
Aichi, 486-8510
JapanActive - Recruiting
Fukuhama Chuo Clinic
Fukuoka, 810-0066
JapanActive - Recruiting
Hasegawa Medicine Clinic
Hokkaido, 066-0032
JapanActive - Recruiting
NTT Medical Center Sapporo
Hokkaido, 060-0061
JapanActive - Recruiting
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo, 114-0001
JapanActive - Recruiting
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok, Podlaskie Voivodeship 15-351
PolandActive - Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
PolandActive - Recruiting
ETG Debica
Dębica, 39-200
PolandActive - Recruiting
Ekamed sp. z o.o.
Lublin, 20-718
PolandActive - Recruiting
NZOZ Eskulap Pabianice
Pabianice, 95-200
PolandActive - Recruiting
Centrum Medyczne OMEDICA
Poznan, 60-111
PolandActive - Recruiting
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c.
Ruda Śląska, 41-709
PolandActive - Recruiting
ETG Siedlce
Siedlce, 08-110
PolandActive - Recruiting
Panstwowy Instytut Medyczny - MSWiA
Warsaw, 02-507
PolandActive - Recruiting
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127
PolandActive - Recruiting
FDI Clinical Research
San Juan, 00927
Puerto RicoActive - Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruna 15006
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
SpainActive - Recruiting
Centro Medico Teknon
Barcelona, 08022
SpainActive - Recruiting
Hospital Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, 41003
SpainActive - Recruiting
Changhua Christian Hospital
Changhua, 50006
TaiwanActive - Recruiting
Chia-Yi Christian Hospital
Chiayi City, 600
TaiwanActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 40447
TaiwanActive - Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan, 70403
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10048
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanActive - Recruiting
Rajavithi Hospital
Bangkok, 10400
ThailandActive - Recruiting
Ramathibodi Hospital
Bangkok, 10400
ThailandActive - Recruiting
Siriraj Hospital
Bangkok, 10700
ThailandActive - Recruiting
Division of Endocrinology and Metabolism;Internal Medicine
Chiang Mai, 50200
ThailandActive - Recruiting
Songklanagarind Hospital
Hat Yai, 90110
ThailandActive - Recruiting
Thammasat University Hospital
Khlong Luang, 12120
ThailandActive - Recruiting
Akdeniz University Medical Faculty
Antalya, 07059
Turkey (Türkiye)Active - Recruiting
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, Lancashire FY3 7EN
United KingdomActive - Recruiting
Aberdeen Royal Infirmary
Aberdeen, AB9 2ZB
United KingdomActive - Recruiting
Antrim Area Hospital
Antrim, BT41 2RL
United KingdomActive - Recruiting
Southmead General Hospital
Bristol, BS10 5NB
United KingdomActive - Recruiting
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, DD1 9SY
United KingdomActive - Recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
United KingdomActive - Recruiting
HMC Health Group
London, TW47NR
United KingdomActive - Recruiting
George Eliot Hospital
Nuneaton, CV10 7DJ
United KingdomActive - Recruiting
Knowle House Surgery
Plymouth, PL5 3JB
United KingdomActive - Recruiting
Lakeview Clinical Research
Guntersville, Alabama 35976
United StatesActive - Recruiting
Arizona Clinical Trials
Tucson, Arizona 85711
United StatesActive - Recruiting
Orange County Research Center
Lake Forest, California 92630
United StatesActive - Recruiting
Ark Clinical Research
Long Beach, California 90815
United StatesActive - Recruiting
Catalina Research Institute, LLC
Montclair, California 91763
United StatesActive - Recruiting
Infinity Clinical Research
Norco, California 92860
United StatesActive - Recruiting
Prospective Research Innovations Inc.
Rancho Cucamonga, California 91730
United StatesActive - Recruiting
Encompass Clinical Research
Spring Valley, California 91978
United StatesActive - Recruiting
Emerson Clinical Research Institute
Washington D.C., District of Columbia 20009
United StatesActive - Recruiting
Tampa Bay Medical Research, Inc.
Clearwater, Florida 33761
United StatesActive - Recruiting
Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida 33024
United StatesActive - Recruiting
Progressive Medical Research
Port Orange, Florida 32127
United StatesActive - Recruiting
Eirvera, LLC
St. Petersburg, Florida 33711
United StatesActive - Recruiting
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia 31904
United StatesActive - Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291
United StatesActive - Recruiting
Elevate Clinical Research
Lake Charles, Louisiana 70605
United StatesActive - Recruiting
DelRicht Clinical Research, LLC
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Centennial Medical Group
Columbia, Maryland 21045-5840
United StatesActive - Recruiting
Centricity Research Morehead City Multispeciality
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Remington Davis Inc
Columbus, Ohio 43215
United StatesActive - Recruiting
Lynn Institute of Norman
Norman, Oklahoma 73072
United StatesActive - Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Essential Medical Research
Tulsa, Oklahoma 74137
United StatesActive - Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina 29405
United StatesActive - Recruiting
Circle Clinical Research
Sioux Falls, South Dakota 57104
United StatesActive - Recruiting
Velocity Clinical Research
Dallas, Texas 75230
United StatesActive - Recruiting
South Texas Research Institute - Edinburg
Edinburg, Texas 78539
United StatesActive - Recruiting
HRI ? Medical Center, LLC
Houston, Texas 77004
United StatesActive - Recruiting
Juno Research, LLC
Houston, Texas 77040
United StatesActive - Recruiting
HRI ? Pasadena, LLC
Pasadena, Texas 77505
United StatesActive - Recruiting
DM Clinical Research
Tomball, Texas 77375
United StatesActive - Recruiting
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesActive - Recruiting
Centricity Research Suffolk Primary Care
Suffolk, Virginia 23435
United StatesActive - Recruiting
Era Health Research
Redmond, Washington 98052
United StatesActive - Recruiting

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