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

NCT ID: NCT07351058
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: 1600 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: * 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 Exclusion Criteria: * 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. * 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

Study locations

204 study locations are listed.

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

Countries: Argentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

New South Wales, Australia: 2
Queensland, Australia: 1
South Australia, Australia: 1
Victoria, Australia: 2
Goiás, Brazil: 1
Rio Grande do Sul, Brazil: 1
São Paulo, Brazil: 4
Sergipe, Brazil: 1
Alberta, Canada: 1
British Columbia, Canada: 1
Ontario, Canada: 3
Quebec, Canada: 2
Hebei, China: 1
Henan, China: 1
Jiangsu, China: 2
Shaanxi, China: 1
Shandong, China: 1
Zhejiang, China: 1
Abruzzo, Italy: 1
Calabria, Italy: 1
Emilia-Romagna, Italy: 1
Lazio, Italy: 2
Lombardy, Italy: 1
Sicily, Italy: 1
Umbria, Italy: 1
Chihuahua, Mexico: 1
Jalisco, Mexico: 2
Mexico, Mexico: 1
Mexico CITY (federal District), Mexico: 2
Morelos, Mexico: 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 Prince Alfred Hospital — Camperdown, New South Wales, 2050, Australia — Site recruitment status not specified in the registry data
Logan Hospital — Meadowbrook, Queensland, 4131, 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
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás — Goiânia, Goiás, 74605-020, 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
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
Clinica do Coracao — Aracaju, Sergipe, 49055-530, Brazil — Site recruitment status not specified in the registry data
IBPCLIN Instituto Brasil de Pesquisa Clinica — Rio de Janeiro, 20241-180, Brazil — Site recruitment status not specified in the registry data
Centricity Research Calgary Endocrinology — Calgary, Alberta, T2H 2G4, Canada — Site recruitment status not specified in the registry data
TGElliott Inc. dba BC Diabetes — Vancouver, British Columbia, V5Y 3W2, Canada — Site recruitment status not specified in the registry data
Centricity Research Brampton Endocrinology — Brampton, Ontario, L6S 0C6, Canada — Site recruitment status not specified in the registry data
Medicor Research Inc — Greater Sudbury, Ontario, P3C 1X3, Canada — Site recruitment status not specified in the registry data

Study details

Start date: March 23, 2026
Primary completion date: August 7, 2028
First posted: January 20, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07351058
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07351058 on ClinicalTrials.gov

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

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