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A Study to Compare Different Doses of RO7795081 With Placebo or Semaglutide in People With Type 2 Diabetes

StatusActive, Not Recruiting
PhasePhase 2
Started2025-08-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 14 months later Nov 27, 2026 → Feb 5, 2028
See other at-risk trials from Roche/Genentech

Amendment history

2026-10-02
Enrollment increased: 240 → 330 participants
Trial arms changed: 9 → 12
Trial sites reduced: 50 → 46 locations
Primary completion pushed: 2026-11-27 → 2028-02-05
Completion pushed: 2026-11-27 → 2028-02-05
2026-07-06
Study Status, Contacts/Locations v13
Study sites50 entries, revised
centroCentro Medico Teknon
2026-04-07
Study Status, Contacts/Locations v12
Trial status changed: Recruiting → Active, Not Recruiting
Primary completion moved earlier: 2027-02-08 → 2026-11-27
Completion moved earlier: 2027-02-08 → 2026-11-27
Study sites51→50
2026-03-10
Study Status, Contacts/Locations v11
Study sites51 entries, revised
Hospital ClínicoUniversitario SanFundación CarlosJimenez Díaz
2026-02-10
Study Status, Contacts/Locations v10
Study sites51 entries, revised
OsrodekNZOZ BadanMETABOLICA O?rodek Bada? Klinicznych Metabolica
Show 9 earlier versions
2026-01-14
Study Status, Contacts/Locations v9
Study sites49→51
2025-12-17
Study Status, Contacts/Locations v8
Study sites46→49
2025-11-17
Study Status, Contacts/Locations v7
Study sites37→46
2025-10-31
Study Status, Contacts/Locations v6
Study sites30→37
2025-10-17
Study Status, Contacts/Locations v5
Study sites22→30
2025-09-17
Study Status, Contacts/Locations v4
Study sites17→22
2025-09-02
Study Status, Contacts/Locations v3
Start dateestimated 2025-08-31→confirmed 2025-08-19
Study sites9→17
2025-08-21
Study Status, Outcome Measures, Contacts/Locations v2
Study sites6→9
Secondary endpoints9 entries, revised
Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 20242025)
2025-08-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→6
2025-08-01
Original filing
Roche/Genentech
364 trials monitored
See 34 trials at risk
Diabetes
4,247 trials monitored
See 176 trials at risk
Type 2 Diabetes
2,082 trials monitored
See 101 trials at risk
This multicenter, randomized, double-blind, placebo- and open-label active comparator-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of different doses of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).
Trial Details
NCT Number NCT07112872
Lead Sponsor Hoffmann-La Roche
Conditions Type 2 Diabetes Mellitus
Enrollment 330 participants
Start Date 2025-08-19
Primary Completion 2028-02-05 (estimated)
Study Completion 2028-02-05 (estimated)
Updated on ClinicalTrials.gov 2026-10-01