A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

Eligibility criteria

Qualifiers

Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to < 30 kg/m² with at least one weight-related comorbidity

History of at least one self-reported unsuccessful dietary effort to lose body weight

Disqualifiers

HbA1c ≥ 48 mmol/mol (6.5%) at screening

History of Type 1 or Type 2 Diabetes

Self-reported change in body weight > 5 kg within 90 days prior to screening

Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed > 1 year prior to or during screening)

Trial design

Treatments tested in this trial

  • Petrelintide
  • Enicepatide
  • Petrelintide-matching Placebo
  • Enicepatide-matching Placebo

Treatment groups

486 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor

Zealand Pharma

Collaborator