AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.
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  • 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

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

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

  • 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

    Recruiting

Other trials in United States

China25 sites, 25 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

    Recruiting

Other trials in China

Germany12 sites, 12 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

    Recruiting

Other trials in Germany

Poland10 sites, 10 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

    Recruiting

Other trials in Poland

South Korea10 sites, 10 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

    Recruiting

Other trials in South Korea

Spain10 sites, 10 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

    Recruiting

Other trials in Spain

United Kingdom10 sites, 10 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

    Recruiting

Other trials in United Kingdom

Mexico9 sites, 9 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

    Recruiting

Other trials in Mexico

Brazil8 sites, 8 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

    Recruiting

Other trials in Brazil

Canada8 sites, 8 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

    Recruiting

Other trials in Canada

Italy8 sites, 8 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

    Recruiting

Other trials in Italy

Taiwan8 sites, 8 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

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)8 sites, 8 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

    Recruiting

Other trials in Turkey (Türkiye)

Argentina7 sites, 7 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

    Recruiting

Other trials in Argentina

Japan7 sites, 7 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

    Recruiting

Other trials in Japan

Australia6 sites, 6 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

    Recruiting

Other trials in Australia

Czechia6 sites, 6 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

    Recruiting

Other trials in Czechia

Thailand6 sites, 6 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

    Recruiting

Other trials in Thailand

France5 sites, 5 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

    Recruiting

Other trials in France

Puerto Rico1 site, 1 recruiting

  • FDI Clinical Research

    San Juan, 00927

    Recruiting

Other trials in Puerto Rico

Romania1 site, 1 recruiting

  • Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu' Timisoara

    Timișoara, 300723

    Recruiting

Other trials in Romania

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).

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 groups in NCT07351058
Study groupRoleWhat they receive
Arm 1: PlaceboPlacebo comparatorNot described
Receives: Combination Product: Placebo
Arm 2: Enicepatide Dosing Regimen 1ExperimentalNot described
Receives: Combination Product: Enicepatide
Arm 3: Enicepatide Dosing Regimen 2ExperimentalNot described
Receives: Combination Product: Enicepatide
Arm 4: Enicepatide Dosing Regimen 3ExperimentalNot described
Receives: Combination Product: Enicepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent (%) Change from Baseline in Body Weight at Week 72

    Measured: Baseline through Week 72

Secondary outcomes (40)

  1. Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72

    Measured: Baseline and Week 72

  2. Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72

    Measured: Baseline and Week 72

  3. Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72

    Measured: Baseline and Week 72

  4. Change from Baseline in Body Weight (kg) at Week 72

    Measured: Baseline through Week 72

  5. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

    Measured: Baseline through Week 72

  6. Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72

    Measured: Week 72

  7. Percentage of Participants Achieving HbA1c of <7% at Week 72

    Measured: Week 72

  8. Change from Baseline in Waist Circumference (cm) at Week 72

    Measured: Baseline through Week 72

  9. Change from Baseline in Fasting Glucose at Week 72

    Measured: Baseline through Week 72

  10. Change from Baseline in Fasting Insulin at Week 72

    Measured: Baseline through Week 72

  11. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72

    Measured: Baseline through Week 72

  12. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72

    Measured: Baseline through Week 72

  13. Change from Baseline in Triglyceride at Week 72

    Measured: Baseline through Week 72

  14. Change from Baseline in Systolic Blood Pressure at Week 72

    Measured: Baseline through Week 72

  15. 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

  16. 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

  17. Change from Baseline in Waist-to-Hip Ratio at Week 72

    Measured: Baseline through Week 72

  18. Change from Baseline in Waist-to-Height Ratio at Week 72

    Measured: Baseline through Week 72

  19. Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72

    Measured: Baseline through Week 72

  20. 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

  21. 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

  22. 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

  23. Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72

    Measured: Baseline and Week 72

  24. Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72

    Measured: Baseline and Week 72

  25. 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

  26. 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

  27. Change from Baseline in Non-HDL Cholesterol at Week 72

    Measured: Baseline through Week 72

  28. Change from Baseline in VLDL Cholesterol at Week 72

    Measured: Baseline through Week 72

  29. Change from Baseline in Total Cholesterol at Week 72

    Measured: Baseline through Week 72

  30. Change from Baseline in Free Fatty Acids at Week 72

    Measured: Baseline through Week 72

  31. Change from Baseline in Diastolic Blood Pressure at Week 72

    Measured: Baseline through Week 72

  32. Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP) at Week 72

    Measured: Baseline through Week 72

  33. Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 72

    Measured: Baseline through Week 72

  34. Change from Baseline in Body Mass Index (BMI) at Week 72

    Measured: Baseline through Week 72

  35. Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72

    Measured: Baseline through Week 72

  36. Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72

    Measured: From Baseline through Week 72

  37. Percentage of Participants Achieving HbA1c of <5.7% at Week 72

    Measured: Week 72

  38. Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria

    Measured: Baseline through Week 72

  39. Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72

    Measured: Baseline through Week 72

  40. 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.

  1. First posted20 Jan 2026
  2. Study start23 Mar 2026
  3. Primary completion7 Aug 2028 (estimated)
  4. Study completion7 Aug 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, China, Germany, Poland, South Korea and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent (%) Change from Baseline in Body Weight at Week 72 (time frame: Baseline through Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07351058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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