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

Study acronym: Enith1
StatusRecruiting
PhasePhase 3
Started2026-03-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
Study Status, Contacts/Locations v10
Trial sites expanded: 195 → 203 locations
2026-08-13
Study Status, Contacts/Locations v9
Trial sites expanded: 164 → 195 locations
2026-07-17
Study Status, Contacts/Locations v8
Trial sites expanded: 128 → 164 locations
2026-06-19
Study Status, Contacts/Locations v7
Trial sites expanded: 73 → 128 locations
2026-05-28
Study Status, Contacts/Locations v6
Trial sites expanded: 58 → 73 locations
2026-05-21
Study Status, Contacts/Locations, References v5
Trial sites expanded: 28 → 58 locations
2026-04-21
Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v4
Trial sites expanded: 22 → 28 locations
InterventionsPlacebo (Combination Product), RO7795068 (Combination Product)→Enicepatide (Combination Product), Placebo (Combination Product)
Study title+14 characters
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
2026-04-06
Study Status, Contacts/Locations v3
Trial sites expanded: 2 → 22 locations
Start dateestimated 2026-03-31→confirmed 2026-03-16
2026-03-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-08-07→2028-07-24
Start date2026-02-27→2026-03-31
Study sites0→2
2026-02-13
Study Status v1
Re-verified, no change to tracked fields
2026-01-16
Original filing
Roche/Genentech
364 trials monitored
See 34 trials at risk
Obesity
3,523 trials monitored
See 133 trials at risk
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.
Trial Details
NCT Number NCT07351045
Lead Sponsor Hoffmann-La Roche
Conditions Obesity or Overweight
Enrollment 2,000 participants
Start Date 2026-03-16
Primary Completion 2028-07-24 (estimated)
Study Completion 2028-08-28 (estimated)
Updated on ClinicalTrials.gov 2026-09-14