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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Study acronym: Enith2
StatusRecruiting
PhasePhase 3
Started2026-03-23
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 193 → 204 locations
2026-08-13
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 163 → 193 locations
2026-07-17
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 122 → 163 locations
2026-06-19
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 61 → 122 locations
2026-05-21
minor
Study Status, Contacts/Locations, References v5
Trial sites expanded: 36 → 61 locations
2026-04-21
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v4
Trial sites expanded: 28 → 36 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 and Type 2 Diabetes
2026-04-13
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 3 → 28 locations
Start dateestimated 2026-03-31→confirmed 2026-03-23
2026-03-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2026-02-27→2026-03-31
Study sites0→3
2026-02-13
minor
Study Status v1
Re-verified, no change to tracked fields
2026-01-16
minor
Original filing
364 trials monitored
See 34 trials at risk
4,247 trials monitored
See 176 trials at risk
3,523 trials monitored
See 133 trials at risk
2,082 trials monitored
See 101 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).
Trial Details
NCT Number NCT07351058
Lead Sponsor Hoffmann-La Roche
Conditions Obesity or Overweight, Type 2 Diabetes Mellitus
Enrollment 1,600 participants
Start Date 2026-03-23
Primary Completion 2028-08-07 (estimated)
Study Completion 2028-08-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-14