AzTrials
AzTrials

Obesity or OverweightPhase 3Enith1NCT07351045

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

A Phase 3 study testing Enicepatide in people with Obesity or Overweight, run by Hoffmann-La Roche at 209 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 without Type 2 diabetes mellitus (T2DM) who have… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity or Overweight
What is being tested?
Enicepatide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
209 sitesin 21 countries
Study dates
16 Mar 2026to 28 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

  • Participants must have at screening:
  • Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
  • BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
  • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
  • Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

Who cannot join

  • History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
  • 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.
  • Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
  • History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
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  • Poorly controlled hypertension at screening
  • 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.
  • Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
  • 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

209 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WC45725 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

209 sites in 21 countries

United States44 sites, 44 recruiting

  • Pinnacle Research Group

    Anniston, Alabama, 36207

    Recruiting

  • Baltimore VA Medical Center

    Baltimore, Maryland, 21201

    Recruiting

  • Johns Hopkins University School of Nursing

    Baltimore, Maryland, 21205

    Recruiting

  • Bellaire Clinical Research, LLC

    Bellaire, Texas, 77401

    Recruiting

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3360

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • South Texas Research Institute - Brownsville

    Brownsville, Texas, 78520

    Recruiting

  • Rochester Clinical Research

    Buffalo, New York, 14217

    Recruiting

  • Innovative Clinical Research

    Clarksville, Tennessee, 37040

    Recruiting

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

    Recruiting

  • University of Texas Southwestern Medical Center - Children's Medical Center Dallas

    Dallas, Texas, 75390

    Recruiting

  • Hometown Urgent Care and Research - Dayton

    Dayton, Ohio, 45424

    Recruiting

  • DelRicht Research at Gulfport Memorial

    Gulfport, Mississippi, 39503

    Recruiting

  • Elevate Clinical Research

    Gurnee, Illinois, 60031

    Recruiting

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

    Recruiting

  • Elevate Clinical

    Houston, Texas, 77058

    Recruiting

  • Houston Research Institute

    Houston, Texas, 77079

    Recruiting

  • University of California Irvine

    Irvine, California, 92612

    Recruiting

  • Monroe Biomedical Research

    Louisville, Kentucky, 40213

    Recruiting

  • Elevate Clinical

    McAllen, Texas, 78504

    Recruiting

  • Ascension Columbia St. Mary's

    Milwaukee, Wisconsin, 53211

    Recruiting

  • International Diabetes Center At Park Nicollet

    Minneapolis, Minnesota, 55416

    Recruiting

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Clinical Research Associates

    Nashville, Tennessee, 37203

    Recruiting

  • Knownwell

    Needham, Massachusetts, 02492

    Recruiting

  • Yale University

    New Haven, Connecticut, 06519

    Recruiting

  • Ascension DePaul Health

    New Orleans, Louisiana, 70127

    Recruiting

  • Headlands Reseach- Summit

    Portland, Oregon, 97210

    Recruiting

  • George E. Wahlen Department of Veterans Affairs Medical Center

    Salt Lake City, Utah, 841480001

    Recruiting

  • Pinnacle Clinical Research - South San Antonio

    San Antonio, Texas, 78222

    Recruiting

  • IMA Clinical Research - San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92123

    Recruiting

  • Knownwell

    Schaumburg, Illinois, 60194

    Recruiting

  • Consano Clinical Research

    Shavano Park, Texas, 78231

    Recruiting

  • Circle Clinical Research

    Sioux Falls, South Dakota, 57104

    Recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Recruiting

  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance

    Southlake, Texas, 76092

    Recruiting

  • Clinvest Research LLC

    Springfield, Missouri, 65807

    Recruiting

  • Arizona Clinical Trials

    Tucson, Arizona, 85711

    Recruiting

  • Delricht Research of Tulsa Clinical Trials

    Tulsa, Oklahoma, 74133

    Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

    Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

    Recruiting

  • Suburban Research Associates - West Chester Office

    West Chester, Pennsylvania, 19380

    Recruiting

Other trials in United States

China15 sites, 15 recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Recruiting

  • Beijing Pinggu Hospital

    Beijing, 101200

    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

  • Hebei Petro China Central Hospital

    Langfang, 065000

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, DUMMY_VALUE

    Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210003

    Recruiting

  • Pingxiang People's Hospital

    Pingxiang, 337000

    Recruiting

  • Shanghai Pudong New Area People's Hospital

    Shanghai, 201299

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215333

    Recruiting

  • Yan'an University Xianyang Hospital

    Xianyang, Shaanxi, 712000

    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

  • 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

  • Medicover Neuroendokrinologie MVZ - Prof. Stalla und Kollegen;Praxis für Neuroendokrinologie

    München, 81667

    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 Specialistyczny Osrodek Internistyczno - Diabetologiczny

    Bialystok, 15-435

    Recruiting

  • Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.

    Bydgoszcz, 85-231

    Recruiting

  • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman

    Gdynia, 81-157

    Recruiting

  • Centrum Medyczne ALL-MED

    Krakow, 30-033

    Recruiting

  • Gabinety Medyczne MATUSZEK

    Lublin, 20-064

    Recruiting

  • Centrum Medyczne Clinicly

    Opole, 45-047

    Recruiting

  • Osrodek Badan Klinicznych Metabolica

    Tarnów, 33-100

    Recruiting

  • Polsko-Amerykanskie Kliniki Serca;X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji

    Tychy, 43-100

    Recruiting

  • ETG Warszawa

    Warsaw, 02-677

    Recruiting

  • ETG Zamosc

    Zamo??, 22-400

    Recruiting

Other trials in Poland

South Korea10 sites, 10 recruiting

  • Kyungpook National University Hospital

    Daegu, Daegu Gwang'yeogsi, 41944

    Recruiting

  • Konyang University Hospital

    Daejeon, 35365

    Recruiting

  • Chosun University Hospital

    Gwangju, 61453

    Recruiting

  • Hanyang University Guri Hospital

    Gyeonggi-do, 11923

    Recruiting

  • Bucheon St Mary's hospital

    Gyeonggi-do, 14647

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

Other trials in South Korea

Spain10 sites, 10 recruiting

  • Hospital San Rafael A Coruna

    A Coruña, LA Coruna, 15006

    Recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Universitario Vall d Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Ruber Juan Bravo

    Madrid, 28006

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

    Recruiting

  • Hospital Vithas Sevilla

    Seville, 41950

    Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, DUMMY_VALUE

    Recruiting

Other trials in Spain

France9 sites, 9 recruiting

  • CHU d'Angers

    Angers, 49933

    Recruiting

  • CHU de Rouen - HOPITAL Bois Guillaume

    Bois-Guillaume, 76230

    Recruiting

  • CHU Dijon - Hopital Francois Mitterrand

    Dijon, DUMMY_VALUE

    Recruiting

  • Hopital Européen Georges Pompidou;Service d?endocrinologie, diabétologie et nutrition

    Paris, 75015

    Recruiting

  • Groupe Hospitalier Pitié Salpétrière;Service d?endocrinologie, diabétologie et nutrition

    Paris, 75671

    Recruiting

  • CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition

    Pessac, 33604

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

  • CHU DE POITIERS - Hôpital de la Milétrie

    Poitiers, 86021

    Recruiting

  • CHU de Nantes - Hopital Laennec

    Saint-Herblain, 44800

    Recruiting

Other trials in France

Italy9 sites, 9 recruiting

  • Policlinico di Bari

    Bari, Apulia, 70124

    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

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

    Recruiting

  • Universita Degli Studi Di Perugia

    Perugia, Umbria, 06129

    Recruiting

  • Università Degli Studi di Pisa - Ospedale di Cisanello Pisa

    Pisa, Tuscany, 56124

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

    Recruiting

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Lombardy, 20097

    Recruiting

Other trials in Italy

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 S.C. Coordinacion

    Cuernavaca, Morelos, 62250

    Recruiting

  • CEMDEC S.A. de C.V.

    Delegacion Cuauhtemoc, Mexico CITY (federal District), 06100

    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

United Kingdom9 sites, 9 recruiting

  • Monklands Hospital

    Airdrie, ML6 0JS

    Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

    Recruiting

  • Rowden Surgery

    Chippenham, Wiltshire, SN15 2SB

    Recruiting

  • Queen Elizabeth University Hospital Glasgow

    Glasgow, G51 4TF

    Recruiting

  • Leicester General Hospital

    Leicester, LE5 4PW

    Recruiting

  • Hammersmith Hospital

    London, W12 0HS

    Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

    Recruiting

  • Soham Staploe Medical Centre

    Soham, Cambridgeshire, CB75JD

    Recruiting

  • Singleton Hospital

    Swansea, SA2 8QA

    Recruiting

Other trials in United Kingdom

Brazil8 sites, 8 recruiting

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, Goiás, 74605-020

    Recruiting

  • Hospital Universitário Onofre Lopes - UFRN

    Natal, Rio Grande do Norte, 59012-300

    Recruiting

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

    Porto Alegre, Rio Grande do Sul, 90430-001

    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

  • BR Trials - Pesquisa Clínica

    São Paulo, São Paulo, 01236-030

    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

  • Aggarwal and Associates

    Brampton, Ontario, L6T 0G1

    Recruiting

  • C-health Partners Inc

    Calgary, Alberta, T2V 4J2

    Recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L 5G4

    Recruiting

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8

    Recruiting

  • Alpha Recherche Clinique

    Québec, G2J0C4

    Recruiting

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3

    Recruiting

  • Unity Healthcare Clinic

    Surrey, British Columbia, V3T 4G8

    Recruiting

  • Diex Recherche Trois-Rivieres

    Trois-Rivières, Quebec, G9A 4P3

    Recruiting

Other trials in Canada

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

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

Hungary7 sites, 7 recruiting

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

    Recruiting

  • Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika

    Budapest, 1122

    Recruiting

  • MED-TIMA Kft.

    Budapest, 1132

    Recruiting

  • Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology

    Budapest, 1213

    Recruiting

  • Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet

    Debrecen, 4032

    Recruiting

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika

    Szeged, 6725

    Recruiting

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center

    Székesfehérvár, 8000

    Recruiting

Other trials in Hungary

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

Czechia6 sites, 6 recruiting

  • MUDr. Alena Váchová, Diabetologie

    České Budějovice, 37011

    Recruiting

  • Edumed s.r.o.;Diabetologická ambulance

    Náchod, 54701

    Recruiting

  • DIALINE s.r.o.

    Plze?, 301 00

    Recruiting

  • MediSpo Clinic

    Prague, 120 00

    Recruiting

  • DiaVize

    Prague, 140 00

    Recruiting

  • MEDICON a.s. - Poliklinika Bud?jovická

    Prague, 140 00

    Recruiting

Other trials in Czechia

India6 sites, 6 recruiting

  • Marengo CIMS Hospital

    Ahmedabad, Gujarat, 380060

    Recruiting

  • Wockhardt Hospitals

    Mumbai, Maharashtra, 400011400011

    Recruiting

  • Grant Medical Foundation, Ruby Hall Clinic

    Pune, Maharashtra, 411001

    Recruiting

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

    Recruiting

  • Chellaram Diabetes Institute;Diabetes and Endocrinology

    Pune, Maharashtra, 411021

    Recruiting

  • Jothydev's Diabetes Research Centre

    Trivandrum, Kerala, 695032

    Recruiting

Other trials in India

Australia5 sites, 5 recruiting

  • Paratus Clinical Western Sydney

    Blacktown, New South Wales, 2148

    Recruiting

  • Heidelberg Repatriation Hospital

    Heidelberg, Victoria, 3081

    Recruiting

  • Baker Heart and Diabetes Insitute

    Melbourne, Victoria, 3004

    Recruiting

  • Southern Adelaide Diabetes and Endocrine Services (SADES)

    Oaklands Park, South Australia, 5046

    Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales, NSW 2065

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300

    Recruiting

  • Hospital Erasme

    Brussels, 1070

    Recruiting

  • UZ Leuven Gasthuisberg

    Leuven, 3000

    Recruiting

  • CHU de Liège (Sart Tilman)

    Liège, 4000

    Recruiting

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Netherlands5 sites, 5 recruiting

  • Amsterdam UMC Location AMC

    Amsterdam, 1105 AZ

    Recruiting

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

    Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD

    Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

    Recruiting

  • Isala

    Zwolle, 8025 AB

    Recruiting

Other trials in Netherlands

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 Without 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Being tested
Placebo, Enicepatide
Medical subject headings
Obesity, Overweight

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 NCT07351045
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 (43)

  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. Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72

    Measured: Baseline and Week 72

  5. Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72

    Measured: Baseline and Week 72

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

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

  8. Change from Baseline in Fasting Glucose at Week 72

    Measured: Baseline through Week 72

  9. Change from Baseline in Fasting Insulin at Week 72

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

  12. Change from Baseline in Triglyceride at Week 72

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

  14. 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

  15. 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

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

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

  18. Percentage of Participants Achieving Normoglycemia (HbA1c <5.7%) at Week 72

    Measured: Baseline and 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 Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire 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 Very Low Density Lipoprotein (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. Percentage of Participants Achieving ≥30% Body Weight Loss from Baseline at Week 72

    Measured: Baseline and 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%, ≥15%, ≥20%, ≥25%, ≥30% Body Weight Loss from Baseline Through Week 72

    Measured: From Baseline through Week 72

  37. Change from Baseline in Total Lean Tissue Volume (Litres) at Week 72, as Assessed by Magnetic Resonance Imaging (MRI)

    Measured: Baseline through Week 72

  38. Percent (%) Change from Baseline in Total Lean Tissue Volume at Week 72, as Assessed by MRI

    Measured: Baseline through Week 72

  39. Change from Baseline in Total Adipose Tissue Volume (Litres) at Week 72, as Assessed by MRI

    Measured: Baseline through Week 72

  40. Percent (%) Change from Baseline in Total Adipose Tissue Volume at Week 72, as Assessed by MRI

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

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

    Measured: Baseline through Week 72

  43. 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 start16 Mar 2026
  3. Primary completion24 Jul 2028 (estimated)
  4. Study completion28 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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07351045
Sponsor's protocol ID
WC45725
Other IDs
2025-523104-71-00, 2025
Acronym
Enith1
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, run by Hoffmann-La Roche at 209 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 5 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 209 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: WC45725 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 NCT07351045.

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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