Petrelintide / Enicepatide-matching Placebo / Enicepatide · Phase 2 Trial

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

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered but not-yet-recruiting Phase 2 trial designed to evaluate the safety and efficacy of a dual GLP-1/GCG receptor agonist combination (petrelintide and enicepatide) versus placebo and monotherapies in adults with obesity or overweight. No outcome data are available from this registry record.

What was studied

Phase 2, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Obesity or Overweight; age from 18 Years. Intervention: Arm 1: Petrelintide + Enicepatide Dosing Regimen 1; Arm 2: Petrelintide + Enicepatide Dosing Regimen 2; Arm 3: Petrelintide + Enicepatide Dosing Regimen 3; Arm 4: Petrelintide-matching Placebo + Enicepatide; Arm 5: Petrelintide + Enicepati…. Compared with: Arm 6: Petrelintide-matching Placebo + Enicepatide-matching… — Placebo Comparator. n = 486.

Key findings

Safety

No efficacy, safety, or outcome data are available; all interpretations must await trial completion and results publication.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a planned Phase 2 dose-finding trial with no results yet reported; registration documents the study design and population but carries no efficacy or safety data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Percentage Change in Body Weight between Arms 1 and 6 (assessed at From Baseline to Week 40)

DesignPhase 2, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationObesity or Overweight; age from 18 Years

Sample size486

InterventionArm 1: Petrelintide + Enicepatide Dosing Regimen 1; Arm 2: Petrelintide + Enicepatide Dosing Regimen 2; Arm 3: Petrelintide + Enicepatide Dosing Regimen 3; Arm 4: Petrelintide-matching Placebo + Enicepatide; Arm 5: Petrelintide + Enicepati…

ComparatorArm 6: Petrelintide-matching Placebo + Enicepatide-matching… — Placebo Comparator

Reported figures

Quoted from the source exactly as published.

Planned enrollment486

PhasePhase 2

Primary endpointPercentage change in body weight between Arms 1 and 6, from baseline to Week 40

Study duration40 weeks

Caveats

This is a registry record only; no results are reported and recruitment has not yet begun (NOT_YET_RECRUITING status).
Trial design details such as blinding, randomisation method, and allocation concealment are not described in the registry record.
Arms structure and assignment of interventions to specific arms are not detailed beyond identifying six arms.
No efficacy, safety, or outcome data are available; all interpretations must await trial completion and results publication.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2, interventional, comparative arms including placebo and monotherapies.

Directness

strong

Directly addresses safety and efficacy in obesity/overweight population.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or trial conduct.

Sample adequacy

moderate

486 estimated participants planned; adequate for Phase 2 dose-finding.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07589686). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 486 participants (ESTIMATED). Conditions: Obesity or Overweight. Interventions: DRUG: Petrelintide; COMBINATION_PRODUCT: Enicepatide; DRUG: Petrelintide-matching Placebo; COMBINATION_PRODUCT: Enicepatide-matching Placebo. Primary outcome measures: Percentage Change in Body Weight between Arms 1 and 6 , From Baseline to Week 40. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

PetrelintideEnicepatide-matching PlaceboNCT07589686EnicepatideObesity Or OverweightHoffmann-La RochePetrelintide-matching Placebo