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

NCT ID: NCT07351045
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 3
Sponsor: Hoffmann-La Roche

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 2000 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or 2. 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) Exclusion Criteria: * 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. * 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

Study locations

203 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, Taiwan, United Kingdom, United States

New South Wales, Australia: 2
South Australia, Australia: 1
Victoria, Australia: 2
Goiás, Brazil: 1
Rio Grande do Norte, Brazil: 1
Rio Grande do Sul, Brazil: 1
São Paulo, Brazil: 5
Alberta, Canada: 1
British Columbia, Canada: 1
Ontario, Canada: 4
Quebec, Canada: 1
Jiangsu, China: 1
Shaanxi, China: 1
Shandong, China: 1
Abruzzo, Italy: 1
Apulia, Italy: 1
Calabria, Italy: 1
Emilia-Romagna, Italy: 1
Lazio, Italy: 1
Lombardy, Italy: 1
Sicily, Italy: 1
Tuscany, Italy: 1
Umbria, Italy: 1
Chihuahua, Mexico: 1
Jalisco, Mexico: 2
Mexico CITY (federal District), Mexico: 3
Morelos, Mexico: 1
Nuevo León, Mexico: 1
Tamaulipas, Mexico: 1
Daegu Gwang'yeogsi, South Korea: 1

Sample of listed locations

CEDIC Centro de Investigaciones Clinicas — Buenos Aires, C1060ABN, Argentina — Site recruitment status not specified in the registry data
Centro Medico Viamonte SRL — Buenos Aires, C1120AAC, Argentina — Site recruitment status not specified in the registry data
CINME — Buenos Aires, C1056ABI, Argentina — Site recruitment status not specified in the registry data
IME - Instituto Médico Especializado — Buenos Aires, C1405BCH, Argentina — Site recruitment status not specified in the registry data
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Ciudad Autonoma Buenos Aires, C1425AGC, Argentina — Site recruitment status not specified in the registry data
Instituto centenario — Ciudad Autonoma Buenos Aires, C1204AAD, Argentina — Site recruitment status not specified in the registry data
Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, B7600FYK, Argentina — Site recruitment status not specified in the registry data
Paratus Clinical Western Sydney — Blacktown, New South Wales, 2148, Australia — Site recruitment status not specified in the registry data
Royal North Shore Hospital — St Leonards, New South Wales, NSW 2065, Australia — Site recruitment status not specified in the registry data
Southern Adelaide Diabetes and Endocrine Services (SADES) — Oaklands Park, South Australia, 5046, Australia — Site recruitment status not specified in the registry data
Heidelberg Repatriation Hospital — Heidelberg, Victoria, 3081, Australia — Site recruitment status not specified in the registry data
Baker Heart and Diabetes Insitute — Melbourne, Victoria, 3004, Australia — Site recruitment status not specified in the registry data
AZORG Campus Aalst-Moorselbaan — Aalst, 9300, Belgium — Site recruitment status not specified in the registry data
Hospital Erasme — Brussels, 1070, Belgium — Site recruitment status not specified in the registry data
UZ Leuven Gasthuisberg — Leuven, 3000, Belgium — Site recruitment status not specified in the registry data
CHU de Liège (Sart Tilman) — Liège, 4000, Belgium — Site recruitment status not specified in the registry data
AZ Delta (Campus Rumbeke) — Roeselare, 8800, Belgium — Site recruitment status not specified in the registry data
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás — Goiânia, Goiás, 74605-020, Brazil — Site recruitment status not specified in the registry data
Hospital Universitário Onofre Lopes - UFRN — Natal, Rio Grande do Norte, 59012-300, Brazil — Site recruitment status not specified in the registry data
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR — Porto Alegre, Rio Grande do Sul, 90430-001, Brazil — Site recruitment status not specified in the registry data
Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, 15090-000, Brazil — Site recruitment status not specified in the registry data
BR Trials - Pesquisa Clínica — São Paulo, São Paulo, 01236-030, Brazil — Site recruitment status not specified in the registry data
Centro de Pesquisas Clinicas — São Paulo, São Paulo, 01228-200, Brazil — Site recruitment status not specified in the registry data
CPQuali Pesquisa Clinica Ltda — São Paulo, São Paulo, 01228-000, Brazil — Site recruitment status not specified in the registry data
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo — São Paulo, São Paulo, 05403-000, Brazil — Site recruitment status not specified in the registry data

Study details

Start date: March 16, 2026
Primary completion date: July 24, 2028
First posted: January 20, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07351045
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07351045 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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