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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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

Qualifiers

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/m²

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Placebo
  • Enicepatide

Treatment groups

1,600 Participants
are divided into 4 treatment groups

Locations

122
Argentina
CEDIC Centro de Investigaciones ClinicasC1060ABN, Buenos Aires Argentina
Centro Medico Viamonte SRLC1120AAC, Buenos Aires Argentina
CINMEC1056ABI, Buenos Aires Argentina
IME - Instituto Médico EspecializadoC1405BCH, Buenos Aires Argentina

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor