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

ConditionObesity 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Petrelintide

    Drug

    Petrelintide will be administered subcutaneously to participants once weekly

  • Enicepatide

    Combination product

    Enicepatide will be administered subcutaneously to participants once weekly

  • Petrelintide-matching Placebo

    Drug

    Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly

  • Enicepatide-matching Placebo

    Combination product

    Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly

Treatment groups

486 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm 1: Petrelintide + Enicepatide Dosing Regimen 1Experimental treatment 2 interventions
Group B: Arm 2: Petrelintide + Enicepatide Dosing Regimen 2Experimental treatment 2 interventions
Group C: Arm 3: Petrelintide + Enicepatide Dosing Regimen 3Experimental treatment 2 interventions
Group D: Arm 4: Petrelintide-matching Placebo + EnicepatideExperimental treatment 2 interventions
Group E: Arm 5: Petrelintide + Enicepatide-matching PlaceboExperimental treatment 2 interventions
Group F: Arm 6: Petrelintide-matching Placebo + Enicepatide-matching PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage Change in Body Weight between Arms 1 and 6

Time frame
From Baseline to Week 40

Secondary outcomes

1

Percentage Change in Body Weight between Arms 2, 3 and Arm 6

Time frame
From Baseline to Week 40
2

Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5

Time frame
From Baseline to Week 40
3

Percentage of Participants Achieving Body Weight Loss

Time frame
From Baseline to Week 40
4

Change in Body Weight (kilograms [kg])

Time frame
From Baseline to Week 40

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Zealand Pharma

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: