Testing a once-weekly drug for weight loss in adults with diabetes
Compares weekly enicepatide with placebo for weight in adults with diabetes.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Key facts
- Where
- Buenos Aires, Ciudad Autonoma Buenos Aires, and Mar del Plata, ArgentinaSee the 7 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes who are overweight or have obesity. It tests the weekly drug enicepatide against placebo for weight management.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes with HbA1c from 6.5% (48 mmol/mol) to 10% (86 mmol/mol) at screening, and a body mass index (BMI) of 27.0 kg/m² or higher.
- Earlier treatment
- Must be on stable oral diabetes treatment for at least 3 months, or diet and exercise alone. Must have tried to lose weight with diet or exercise at least once without success. Cannot have used any GLP-1 receptor agonist-based drug within 6 months before randomization. DPP-4 inhibitors are not allowed.
- Biomarker or test result
- HbA1c from 6.5% (48 mmol/mol) to 10% (86 mmol/mol) on a laboratory test at screening.
Main reasons for not taking part
- Type 1 diabetes, or ever had ketoacidosis
- Severe low blood sugar in the last 6 months, or not noticing low blood sugar
- Weight change of more than 5 kg (11 lb) in the last 3 months
- Obesity caused by another hormone disease or by a genetic condition
- Heart attack, stroke, unstable angina or hospital stay for heart failure in the last 3 months
Read by machine on 10 November 2026.
Where in Argentina
- CEDIC Centro de Investigaciones ClinicasBuenos Aires, ArgentinaTaking people
- Centro Medico Viamonte SRLBuenos Aires, ArgentinaTaking people
- CINMEBuenos Aires, ArgentinaTaking people
- IME - Instituto Médico EspecializadoBuenos Aires, ArgentinaTaking people
- Centro Medico Dra. Laura Maffei - Investigacion Clinica AplicadaCiudad Autonoma Buenos Aires, ArgentinaTaking people
- Instituto centenarioCiudad Autonoma Buenos Aires, ArgentinaTaking people
- Centro de Investigaciones Medicas Mar Del PlataMar del Plata, ArgentinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07351058EU 2025-523106-32-00
- Record updated
- 9 November 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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; Self-reported change in body weight >5 kg within 3 months prior to screening; Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed; 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; 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); Poorly controlled hypertension at screening; At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening; Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction).