Enicepatide / Obesity Or Overweight · Phase 3 Trial

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

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

AI Summary

This is an ongoing Phase 3 registry record for enicepatide, a dual GLP-1/GIP receptor agonist, in participants with obesity or overweight without type 2 diabetes. No efficacy or safety results are reported in this registry entry; the study is currently recruiting and results are not yet available.

What was studied

Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Obesity or Overweight; age from 18 Years. Intervention: Arm 2: Enicepatide Dosing Regimen 1; Arm 3: Enicepatide Dosing Regimen 2; Arm 4: Enicepatide Dosing Regimen 3. Compared with: Arm 1: Placebo — Placebo Comparator. n = 2,000. 195 sites across 20 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported

Who this may help

Results from this trial, when published, will inform the efficacy and safety of enicepatide for weight management in non-diabetic populations. Clinicians should await peer-reviewed publication of final results before drawing conclusions.

Plain-language summary

This is an active Phase 3 registry record with no reported results; the study is still recruiting and outcome data are not yet available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Percent (%) Change from Baseline in Body Weight at Week 72 (assessed at Baseline through Week 72)

DesignPhase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationObesity or Overweight; age from 18 Years

Sample size2,000

InterventionArm 2: Enicepatide Dosing Regimen 1; Arm 3: Enicepatide Dosing Regimen 2; Arm 4: Enicepatide Dosing Regimen 3

ComparatorArm 1: Placebo — Placebo Comparator

Setting195 sites across 20 countries

Reported figures

Quoted from the source exactly as published.

Planned sample size2000

Primary outcome measurePercent change from baseline in body weight at Week 72

Study phasePhase 3

Study duration72 weeks

Clinical bottom line

Caveats

This is a registry record only; no efficacy or safety results are reported
Study is still recruiting; outcome data collection and analysis are not complete
Specific enrollment criteria and baseline characteristics not detailed in registry record
No comparator dose details or stratification strategy provided

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

strong

Phase 3, randomized, placebo-controlled interventional trial design

Directness

strong

Directly addresses weight management in obesity or overweight without T2DM

Consistency

insufficient

No results reported; consistency cannot be assessed

Risk of bias

insufficient

Registry record only; no conduct detail provided to assess bias risk

Sample adequacy

strong

Estimated enrollment 2000 participants adequate for Phase 3 weight loss trial

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 (NCT07351045). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 2000 participants (ESTIMATED). Conditions: Obesity or Overweight. Interventions: COMBINATION_PRODUCT: Placebo; COMBINATION_PRODUCT: Enicepatide. Primary outcome measures: Percent (%) Change from Baseline in Body Weight at Week 72 , Baseline through Week 72. Brief summary: 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 without Type 2 diabetes mellitus (T2DM) who have 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.

EnicepatideObesity Or OverweightNCT07351045Hoffmann-La Roche