A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Last updated: June 19, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Obesity

Diabetes Prevention

Treatment

RO7795068

Placebo

Enicepatide

Clinical Study ID

NCT07351058
WC45726
2025-523106-32-00
  • Ages > 18
  • All Genders

Study 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 mellitus (T2DM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability and willingness to self-administer the study drug (or receive an injectionfrom a trained individual if visually impaired or with physical limitations)

  • Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification orother locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratorytest at screening, and on stable oral therapy for at least 3 months prior toscreening (if applicable). T2DM may be treated with diet/exercise alone or any oralanti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.

  • Body mass index (BMI) ≥27.0 kg/m^2

  • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion

Exclusion Criteria:

  • History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosisor history of hyperosmolar state/coma within 12 months prior to screening

  • Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemiaunawareness within the 6 months prior to screening

  • At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2non-consecutive days) during screening

  • Self-reported change in body weight >5 kg within 3 months prior to screening

  • Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) ordiagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptordeficiency or Prader-Willi syndrome)

  • Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty ifperformed more than 1 year prior to screening is allowed.

  • Known clinically significant gastric emptying abnormality (e.g., severegastroparesis or gastric outlet obstruction)

  • Poorly controlled hypertension at screening

  • Have any of the following cardiovascular conditions within 3 months prior toscreening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transientischemic attack; Unstable angina; Hospitalization due to congestive heart failure

  • Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptortriple agonist) within 6 months prior to randomization

Study Design

Total Participants: 1600
Treatment Group(s): 3
Primary Treatment: RO7795068
Phase: 3
Study Start date:
March 23, 2026
Estimated Completion Date:
August 07, 2028

Connect with a study center

  • CEDIC Centro de Investigaciones Clinicas

    Buenos Aires, C1060ABN
    Argentina

    Active - Recruiting

  • CINME

    Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Centro Medico Viamonte SRL

    Buenos Aires, C1120AAC
    Argentina

    Active - Recruiting

  • IME - Instituto Médico Especializado

    Buenos Aires, C1405BCH
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires, C1425AGC
    Argentina

    Active - Recruiting

  • Instituto centenario

    Ciudad Autonoma Buenos Aires, C1204AAD
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK
    Argentina

    Active - Recruiting

  • Paratus Clinical Western Sydney

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Logan Hospital

    Meadowbrook, Queensland 4131
    Australia

    Active - Recruiting

  • Southern Adelaide Diabetes and Endocrine Services (SADES)

    Oaklands Park, South Australia 5046
    Australia

    Active - Recruiting

  • Baker Heart and Diabetes Insitute

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta T2H 2G4
    Canada

    Active - Recruiting

  • Dr TG Elliott Inc

    Vancouver, British Columbia V5Y 3W2
    Canada

    Active - Recruiting

  • TGElliott Inc. dba BC Diabetes

    Vancouver, British Columbia V5Y 3W2
    Canada

    Active - Recruiting

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario L6S 0C6
    Canada

    Active - Recruiting

  • Medicor Research Inc

    Greater Sudbury, Ontario P3C 1X3
    Canada

    Active - Recruiting

  • LMC Clinical Research Inc

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec J1L 0H8
    Canada

    Active - Recruiting

  • Clinique des maladies lipidiques de Quebec

    Québec, G1V 4W2
    Canada

    Active - Recruiting

  • Yan'an University Xianyang Hospital

    Xianyang, Shaanxi 712000
    China

    Active - Recruiting

  • Beijing Pinggu Hospital

    Beijing, 101200
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, 100044
    China

    Active - Recruiting

  • The Second People's Hospital of Hefei

    Hefei, 230011
    China

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  • Huizhou Central People's Hospital

    Huizhou, 516001
    China

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  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210003
    China

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  • Shanghai Fifth People's Hospital Affiliated to Fudan University

    Shanghai, 201304
    China

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  • Shanghai Pudong New Area People's Hospital

    Shanghai, 201299
    China

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  • TreDia s.r.o.;Diabetologická ambulance Praha 9

    Praha 9 - Klánovice, 19014
    Czechia

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  • Hopital de la Conception

    Marseille, 13000
    France

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  • CHU de Nice

    Nice, 06602
    France

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  • European Hospital Georges Pompidou (HEGP)

    Paris, 75908
    France

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  • Chu De Tours

    Tours, 37000
    France

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  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

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  • Medizentrum Essen Borbeck

    Essen, 45355
    Germany

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  • Unterfrintroper Hausarztzentrum

    Essen, 45359
    Germany

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  • Diabeteszentrum Hamburg West

    Hamburg, 22607
    Germany

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  • Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie

    Hof, 95030
    Germany

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  • Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung

    Pirna, 01796
    Germany

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  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

    Bologna, Emilia-Romagna 40138
    Italy

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  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio 00168
    Italy

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  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio 00161
    Italy

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  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily 90127
    Italy

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  • Universita Degli Studi Di Perugia

    Perugia, Umbria 06129
    Italy

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  • Kasugai Municipal Hospital

    Aichi, 486-8510
    Japan

    Active - Recruiting

  • Fukuhama Chuo Clinic

    Fukuoka, 810-0066
    Japan

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  • Hasegawa Medicine Clinic

    Hokkaido, 066-0032
    Japan

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  • NTT Medical Center Sapporo

    Hokkaido, 060-0061
    Japan

    Active - Recruiting

  • Higashijujo Sakai Diabetes Internal Medicine Clinic

    Tokyo, 114-0001
    Japan

    Active - Recruiting

  • NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik

    Bialystok, Podlaskie Voivodeship 15-351
    Poland

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  • Centrum Medyczne INTERCOR Sp. z o.o.

    Bydgoszcz, 85-605
    Poland

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  • ETG Debica

    Dębica, 39-200
    Poland

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  • Ekamed sp. z o.o.

    Lublin, 20-718
    Poland

    Active - Recruiting

  • NZOZ Eskulap Pabianice

    Pabianice, 95-200
    Poland

    Active - Recruiting

  • Centrum Medyczne OMEDICA

    Poznan, 60-111
    Poland

    Active - Recruiting

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c.

    Ruda Śląska, 41-709
    Poland

    Active - Recruiting

  • ETG Siedlce

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny - MSWiA

    Warsaw, 02-507
    Poland

    Active - Recruiting

  • NZOZ Regionalna Poradnia Diabetologiczna

    Wroclaw, 50-127
    Poland

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  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, LA Coruna 15006
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid 28223
    Spain

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  • Centro Medico Teknon

    Barcelona, 08022
    Spain

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  • Hospital Gregorio Marañon

    Madrid, 28007
    Spain

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  • Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003
    Spain

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  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

    Active - Recruiting

  • Chia-Yi Christian Hospital

    Chiayi City, 600
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756
    Taiwan

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  • China Medical University Hospital

    Taichung, 40447
    Taiwan

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  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

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  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Rajavithi Hospital

    Bangkok, 10400
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital

    Bangkok, 10400
    Thailand

    Active - Recruiting

  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Division of Endocrinology and Metabolism;Internal Medicine

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Songklanagarind Hospital

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Thammasat University Hospital

    Khlong Luang, 12120
    Thailand

    Active - Recruiting

  • Akdeniz University Medical Faculty

    Antalya, 07059
    Turkey (Türkiye)

    Active - Recruiting

  • Fylde Coast Clinical Research at Layton Medical Centre

    Blackpool, Lancashire FY3 7EN
    United Kingdom

    Active - Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB9 2ZB
    United Kingdom

    Active - Recruiting

  • Antrim Area Hospital

    Antrim, BT41 2RL
    United Kingdom

    Active - Recruiting

  • Southmead General Hospital

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital and Medical School - Tayside Health Board

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

    Active - Recruiting

  • HMC Health Group

    London, TW47NR
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital

    Nuneaton, CV10 7DJ
    United Kingdom

    Active - Recruiting

  • Knowle House Surgery

    Plymouth, PL5 3JB
    United Kingdom

    Active - Recruiting

  • Lakeview Clinical Research

    Guntersville, Alabama 35976
    United States

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  • Arizona Clinical Trials

    Tucson, Arizona 85711
    United States

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  • Orange County Research Center

    Lake Forest, California 92630
    United States

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  • Ark Clinical Research

    Long Beach, California 90815
    United States

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  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

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  • Infinity Clinical Research

    Norco, California 92860
    United States

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  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California 91730
    United States

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  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

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  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia 20009
    United States

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  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • Center for Diabetes, Obesity and Metabolism Inc

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Eirvera, LLC

    St. Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Active - Recruiting

  • Elevate Clinical Research

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • DelRicht Clinical Research, LLC

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Centennial Medical Group

    Columbia, Maryland 21045-5840
    United States

    Active - Recruiting

  • Centricity Research Morehead City Multispeciality

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Remington Davis Inc

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Lynn Institute of Norman

    Norman, Oklahoma 73072
    United States

    Active - Recruiting

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Essential Medical Research

    Tulsa, Oklahoma 74137
    United States

    Active - Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Circle Clinical Research

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • South Texas Research Institute - Edinburg

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • HRI ? Medical Center, LLC

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • HRI ? Pasadena, LLC

    Pasadena, Texas 77505
    United States

    Active - Recruiting

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Centricity Research Suffolk Primary Care

    Suffolk, Virginia 23435
    United States

    Active - Recruiting

  • Era Health Research

    Redmond, Washington 98052
    United States

    Active - Recruiting

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