Obesity or OverweightPhase 3Enith2NCT07351058
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
A Phase 3 study testing Enicepatide in people with Obesity or Overweight and Type 2 Diabetes Mellitus, run by Hoffmann-La Roche at 210 sites in 21 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity or Overweight, Type 2 Diabetes Mellitus
- What is being tested?
- Enicepatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,600 participants
- Where
- 210 sitesin 21 countries
- Study dates
- 23 Mar 2026to 7 Aug 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-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
Who cannot join
- History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
- Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
- At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-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) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
Show all 10Show fewer
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- Poorly controlled hypertension at screening
- Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
- Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
Trial locations and contacts
210 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
210 sites in 21 countries
United States45 sites, 45 recruiting
- Recruiting
Elite Clinical Trials
Blackfoot, Idaho, 83221
- Recruiting
Headlands Research Brownsville
Brownsville, Texas, 78526
- Recruiting
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
- Recruiting
Centennial Medical Group
Columbia, Maryland, 21045-5840
- Recruiting
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, 31904
- Recruiting
Remington Davis Inc
Columbus, Ohio, 43215
- Recruiting
Velocity Clinical Research
Dallas, Texas, 75230
- Recruiting
Atlanta Veterans Affairs Medical Center
Decatur, Georgia, 30033
- Recruiting
South Texas Research Institute - Edinburg
Edinburg, Texas, 78539
- Recruiting
Lakeview Clinical Research
Guntersville, Alabama, 35976
- Recruiting
HRI ? Medical Center, LLC
Houston, Texas, 77004
- Recruiting
Juno Research, LLC
Houston, Texas, 77040
- Recruiting
University of California Irvine
Irvine, California, 92612
- Recruiting
Kansas City VA Medical Center
Kansas City, Missouri, 64128
- Recruiting
Elevate Clinical Research
Lake Charles, Louisiana, 70605
- Recruiting
Orange County Research Center
Lake Forest, California, 92630
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
- Recruiting
Manassas Clinical Research Center
Manassas, Virginia, 20110
- Recruiting
Nola Care Clinical Research Center
Metairie, Louisiana, 70006
- Recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
- Recruiting
Centricity Research Morehead City Multispeciality
Morehead City, North Carolina, 28557
- Recruiting
DelRicht Clinical Research, LLC
New Orleans, Louisiana, 70115
- Recruiting
Infinity Clinical Research
Norco, California, 92860
- Recruiting
Lynn Institute of Norman
Norman, Oklahoma, 73072
- Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
- Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
- Recruiting
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
- Recruiting
HRI ? Pasadena, LLC
Pasadena, Texas, 77505
- Recruiting
Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida, 33024
- Recruiting
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
- Recruiting
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
- Recruiting
Era Health Research
Redmond, Washington, 98052
- Recruiting
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
- Recruiting
Circle Clinical Research
Sioux Falls, South Dakota, 57104
- Recruiting
Encompass Clinical Research
Spring Valley, California, 91978
- Recruiting
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, 62711
- Recruiting
Eirvera, LLC
St. Petersburg, Florida, 33711
- Recruiting
Centricity Research Suffolk Primary Care
Suffolk, Virginia, 23435
- Recruiting
DM Clinical Research
Tomball, Texas, 77375
- Recruiting
Arizona Clinical Trials
Tucson, Arizona, 85711
- Recruiting
Essential Medical Research
Tulsa, Oklahoma, 74137
- Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
- Recruiting
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
China25 sites, 25 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
- Recruiting
Beijing Pinggu Hospital
Beijing, 101200
- Recruiting
Cangzhou People's Hospital
Cangzhou, Hebei, 061011
- Recruiting
The First Hospital of Jilin University
Changchun, 130021
- Recruiting
The Second People's Hospital of Hefei
Hefei, 230011
- Recruiting
The Fourth Affiliated Hospital of Harbin Medical University
Herbin, 150001
- Recruiting
Huizhou Central People's Hospital
Huizhou, 516001
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
Huai He Hospital of Henan University
Kaifeng, Henan, 475001
- Recruiting
Hebei Petro China Central Hospital
Langfang, 065000
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210003
- Recruiting
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, 210008
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
- Recruiting
Pingxiang People's Hospital
Pingxiang, 337000
- Recruiting
Shanghai Pudong New Area People's Hospital
Shanghai, 201299
- Recruiting
Shanghai Fifth People's Hospital Affiliated to Fudan University
Shanghai, 201304
- Recruiting
Siping Central People's Hospital
Siping, 136001
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, 215333
- Recruiting
Wuxi People's Hospital
Wuxi, 214023
- Recruiting
The First Affiliated Hospital of Xi'an Medical University
Xi'an, 710077
- Recruiting
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
- Recruiting
Yueyang Central Hospital
Yueyang, 414000
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212002
Germany12 sites, 12 recruiting
- Recruiting
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Medizinische Fakultät OWL (Universität Bielefeld);Klinik für Diabetologie und Endokrinologie
Bad Oeynhausen, 32545
- Recruiting
Hector-Center für Ernährung, Bewegung und Sport, Universitätsklinikum Erlangen;Medizinische Klinik 1 ? Gastroenterologie, Pneumologie und Endokrinologie
Erlangen, 91054
- Recruiting
InnoDiab Forschung GmbH
Essen, 45136
- Recruiting
Medizentrum Essen Borbeck
Essen, 45355
- Recruiting
Unterfrintroper Hausarztzentrum
Essen, 45359
- Recruiting
Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin
Frankfurt, 60596
- Recruiting
MVZ Diabeteszentrum Dr. Tews GmbH;Praxis für Diabetologie
Gelnhausen, 63571
- Recruiting
Diabeteszentrum Hamburg West
Hamburg, 22607
- Recruiting
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
Hof, 95030
- Recruiting
Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis
Köln - Dünnwald, 51069
- Recruiting
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried Keuthage
Münster, 48153
- Recruiting
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung
Pirna, 01796
Poland10 sites, 10 recruiting
- Recruiting
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok, Podlaskie Voivodeship, 15-351
- Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
- Recruiting
ETG Debica
Dębica, 39-200
- Recruiting
Ekamed sp. z o.o.
Lublin, 20-718
- Recruiting
NZOZ Eskulap Pabianice
Pabianice, 95-200
- Recruiting
Centrum Medyczne OMEDICA
Poznan, 60-111
- Recruiting
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c.
Ruda Śląska, 41-709
- Recruiting
ETG Siedlce
Siedlce, 08-110
- Recruiting
Panstwowy Instytut Medyczny - MSWiA
Warsaw, 02-507
- Recruiting
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127
South Korea10 sites, 10 recruiting
- Recruiting
Eulji University Hospital
Daejeon, 35233
- Recruiting
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 26426
- Recruiting
Chosun University Hospital
Gwangju, 61453
- Recruiting
Uijeongbu St. Mary's Hospital
Gyeonggi-do, 11765
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
- Recruiting
Eulji General Hospital
Seoul, 01830
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Gangdong Kyung Hee University Hospital
Seoul, 05278
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Spain10 sites, 10 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruna, 15006
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
- Recruiting
Centro Medico Teknon
Barcelona, 08022
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, 08035
- Recruiting
Complejo Hospitalario Universitario de Ferrol
Ferrol, LA Coruna, 15405
- Recruiting
Hospital Gregorio Marañon
Madrid, 28007
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
- Recruiting
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, 41003
United Kingdom10 sites, 10 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, AB9 2ZB
- Recruiting
Antrim Area Hospital
Antrim, BT41 2RL
- Recruiting
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, Lancashire, FY3 7EN
- Recruiting
Southmead General Hospital
Bristol, BS10 5NB
- Recruiting
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, DD1 9SY
- Recruiting
HMC Health Group
Hounslow, TW4 7NR
- Recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
- Recruiting
George Eliot Hospital
Nuneaton, CV10 7DJ
- Recruiting
Knowle House Surgery
Plymouth, PL5 3JB
- Recruiting
Musgrove Park Hospital
Taunton, TA1 5DA
Mexico9 sites, 9 recruiting
- Recruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares SC
Ciudad Madero, Tamaulipas, 89440
- Recruiting
Medical Center Metas SC
Col Saucito, Chihuahua, 31110
- Recruiting
Instituto de Diabetes Obesidad y Nutricion, SC
Cuernavaca, Morelos, 62250
- Recruiting
CEMDEC S.A. de C.V.
Delegacion Cuauhtemoc, Mexico, 6100
- Recruiting
Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44650
- Recruiting
Instituto Jalisciense de investigacion en diabetes y obesidad S.C.
Guadalajara, Jalisco, 44650
- Recruiting
Clinicos Asociados Bocm, S.C.
México, Mexico CITY (federal District), 03300
- Recruiting
Instittuto Nacional de Ciencias Medicas y Nutricion "Salvador Subiran"
México, Mexico CITY (federal District), 14000
- Recruiting
Avant Santé Research Center
San Pedro Garza García, Nuevo León, 66260
Brazil8 sites, 8 recruiting
- Recruiting
Clinica do Coracao
Aracaju, Sergipe, 49055-530
- Recruiting
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, 74605-020
- Recruiting
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, 90430-001
- Recruiting
IBPCLIN Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180
- Recruiting
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
- Recruiting
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, 01228-000
- Recruiting
Centro de Pesquisas Clinicas
São Paulo, São Paulo, 01228-200
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Canada8 sites, 8 recruiting
- Recruiting
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6
- Recruiting
Centricity Research Calgary Endocrinology
Calgary, Alberta, T2H 2G4
- Recruiting
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3
- Recruiting
Applied Medical Informatics Research Inc. (A.M.I.R.)
Montreal, Quebec, H4A 3T2
- Recruiting
Clinique des maladies lipidiques de Quebec
Québec, G1V 4W2
- Recruiting
Diex Recherche Sherbrooke East
Sherbrooke, Quebec, J1E 0N8
- Recruiting
LMC Clinical Research Inc
Toronto, Ontario, M4G 3E8
- Recruiting
TGElliott Inc. dba BC Diabetes
Vancouver, British Columbia, V5Y 3W2
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Abruzzo, 24127
- Recruiting
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138
- Recruiting
Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro
Catanzaro, Calabria, 88100
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, 90127
- Recruiting
AO di Perugia - Ospedale S. Maria della Misericordia
Perugia, Umbria, 06156
- Recruiting
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, 00161
- Recruiting
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
Taiwan8 sites, 8 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 50006
- Recruiting
Chia-Yi Christian Hospital
Chiayi City, 600
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
- Recruiting
National Taiwan University Hospital
Taipei, 10048
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370
- Recruiting
Ankara University Medical Faculty
Ankara, 06100
- Recruiting
Akdeniz University Medical Faculty
Antalya, 07059
- Recruiting
Koc University Medical Faculty Hospital
Istanbul, Zeytinburnu, 34010
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
- Recruiting
Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34668
- Recruiting
Dokuz Eylul University Medicine Faculty
Izmir, 35340
- Recruiting
Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi
Sariçam, 01250
Argentina7 sites, 7 recruiting
- Recruiting
CINME
Buenos Aires, C1056ABI
- Recruiting
CEDIC Centro de Investigaciones Clinicas
Buenos Aires, C1060ABN
- Recruiting
Centro Medico Viamonte SRL
Buenos Aires, C1120AAC
- Recruiting
IME - Instituto Médico Especializado
Buenos Aires, C1405BCH
- Recruiting
Instituto centenario
Ciudad Autonoma Buenos Aires, C1204AAD
- Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, C1425AGC
- Recruiting
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK
Japan7 sites, 7 recruiting
- Recruiting
Kasugai Municipal Hospital
Aichi, 486-8510
- Recruiting
Fukuhama Chuo Clinic
Fukuoka, 810-0066
- Recruiting
NTT Medical Center Sapporo
Hokkaido, 060-0061
- Recruiting
Hasegawa Medicine Clinic
Hokkaido, 066-0032
- Recruiting
The University of Osaka Hospital
Osaka, 565-0871
- Recruiting
The University of Tokyo Hospital
Tokyo, 113-8655
- Recruiting
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo, 114-0001
Australia6 sites, 6 recruiting
- Recruiting
Paratus Clinical Western Sydney
Blacktown, New South Wales, 2148
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
- Recruiting
Heidelberg Repatriation Hospital
Heidelberg, Victoria, 3081
- Recruiting
Logan Hospital
Meadowbrook, Queensland, 4131
- Recruiting
Baker Heart and Diabetes Insitute
Melbourne, Victoria, 3004
- Recruiting
Southern Adelaide Diabetes and Endocrine Services (SADES)
Oaklands Park, South Australia, 5046
Czechia6 sites, 6 recruiting
- Recruiting
DIACENTRUM Brandýs nad Labem s.r.o.
Brandýs nad Labem, 25001
- Recruiting
Diavital Jesenice s.r.o.
Jesenice, 25242
- Recruiting
Institut klinické a experimentální medicíny (IKEM);centrum diabetologie
Prague, 14021
- Recruiting
FLEDIP s.r.o.
Prague, 160 00
- Recruiting
Úst?ední vojenská nemocnice;Diabetologické centrum
Prague, 162 00
- Recruiting
TreDia s.r.o.;Diabetologická ambulance Praha 9
Praha 9 - Klánovice, 19014
Thailand6 sites, 6 recruiting
- Recruiting
Rajavithi Hospital
Bangkok, 10400
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Division of Endocrinology and Metabolism;Internal Medicine
Chiang Mai, 50200
- Recruiting
Songklanagarind Hospital
Hat Yai, 90110
- Recruiting
Thammasat University Hospital
Khlong Luang, 12120
France5 sites, 5 recruiting
- Recruiting
Hopital Saint Joseph Saint Luc
Lyon, 69007
- Recruiting
Hopital de la Conception
Marseille, 13000
- Recruiting
CHU de Nice
Nice, 06602
- Recruiting
European Hospital Georges Pompidou (HEGP)
Paris, 75908
- Recruiting
Chu De Tours
Tours, 37000
Puerto Rico1 site, 1 recruiting
- Recruiting
FDI Clinical Research
San Juan, 00927
Romania1 site, 1 recruiting
- Recruiting
Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu' Timisoara
Timișoara, 300723
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
- Conditions
- Obesity or Overweight, Type 2 Diabetes Mellitus
- Being tested
- Placebo, Enicepatide
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboCombination product
Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
EnicepatideCombination product
Also called RO7795068, CT-388, RG6640
Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
| Arm 2: Enicepatide Dosing Regimen 1 | Experimental | Not described Receives: Combination Product: Enicepatide |
| Arm 3: Enicepatide Dosing Regimen 2 | Experimental | Not described Receives: Combination Product: Enicepatide |
| Arm 4: Enicepatide Dosing Regimen 3 | Experimental | Not described Receives: Combination Product: Enicepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) Change from Baseline in Body Weight at Week 72
Measured: Baseline through Week 72
Secondary outcomes (40)
Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72
Measured: Baseline and Week 72
Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72
Measured: Baseline and Week 72
Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72
Measured: Baseline and Week 72
Change from Baseline in Body Weight (kg) at Week 72
Measured: Baseline through Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Measured: Baseline through Week 72
Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72
Measured: Week 72
Percentage of Participants Achieving HbA1c of <7% at Week 72
Measured: Week 72
Change from Baseline in Waist Circumference (cm) at Week 72
Measured: Baseline through Week 72
Change from Baseline in Fasting Glucose at Week 72
Measured: Baseline through Week 72
Change from Baseline in Fasting Insulin at Week 72
Measured: Baseline through Week 72
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72
Measured: Baseline through Week 72
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72
Measured: Baseline through Week 72
Change from Baseline in Triglyceride at Week 72
Measured: Baseline through Week 72
Change from Baseline in Systolic Blood Pressure at Week 72
Measured: Baseline through Week 72
Change from Baseline in the Physical Functioning Domain Score of the Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form at Week 72
Measured: Baseline through Week 72
Change from Baseline in Physical Functioning Composite Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 72
Measured: Baseline through Week 72
Change from Baseline in Waist-to-Hip Ratio at Week 72
Measured: Baseline through Week 72
Change from Baseline in Waist-to-Height Ratio at Week 72
Measured: Baseline through Week 72
Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72
Measured: Baseline through Week 72
Change from Baseline in Symptoms and Impact of Urinary Incontinence as Assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72
Measured: Baseline through Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Change (PGI-C) Urinary Incontinence Questionnaire at Week 72
Measured: Baseline and Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Severity (PGI-S) Urinary Incontinence Questionnaire at Week 72
Measured: Baseline and Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72
Measured: Baseline and Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72
Measured: Baseline and Week 72
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Form Domain Scores and Component Summary Scores at Week 72
Measured: Baseline through Week 72
Change from Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Domain Scores and Total Score at Week 72
Measured: Baseline through Week 72
Change from Baseline in Non-HDL Cholesterol at Week 72
Measured: Baseline through Week 72
Change from Baseline in VLDL Cholesterol at Week 72
Measured: Baseline through Week 72
Change from Baseline in Total Cholesterol at Week 72
Measured: Baseline through Week 72
Change from Baseline in Free Fatty Acids at Week 72
Measured: Baseline through Week 72
Change from Baseline in Diastolic Blood Pressure at Week 72
Measured: Baseline through Week 72
Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP) at Week 72
Measured: Baseline through Week 72
Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 72
Measured: Baseline through Week 72
Change from Baseline in Body Mass Index (BMI) at Week 72
Measured: Baseline through Week 72
Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72
Measured: Baseline through Week 72
Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72
Measured: From Baseline through Week 72
Percentage of Participants Achieving HbA1c of <5.7% at Week 72
Measured: Week 72
Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria
Measured: Baseline through Week 72
Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72
Measured: Baseline through Week 72
Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score Through Week 72
Measured: Baseline through Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start23 Mar 2026
- Primary completion7 Aug 2028 (estimated)
- Study completion7 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351058
- Sponsor's protocol ID
- WC45726
- Other IDs
- 2025-523106-32-00, 2025
- Acronym
- Enith2
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing