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A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants with Type 2 Diabetes Mellitus

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520322-11-00
Acronym
BP45703
Enrollment
74
Registered
2025-09-05
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2D)

Brief summary

Change in HbA1c from baseline at Week 30

Detailed description

Change in HbA1c from baseline at Week 30, Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30, Change in fasting plasma glucose from baseline at Week 30, Percent (%) change in body weight from baseline at Week 30, Absolute change in body weight (kg) from baseline at Week 30, Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30, Incidence of AEs, AESIs, and SAEs, Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024), Change in safety laboratory values and vital signs, Change in ECG parameters, Plasma concentrations of RO7795081

Interventions

DRUGoral GLP-1R agonist (CT-996) Capsule
DRUGhard 0 mg / 1 EA - F10

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in HbA1c from baseline at Week 30

Secondary

MeasureTime frame
Change in HbA1c from baseline at Week 30, Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30, Change in fasting plasma glucose from baseline at Week 30, Percent (%) change in body weight from baseline at Week 30, Absolute change in body weight (kg) from baseline at Week 30, Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30, Incidence of AEs, AESIs, and SAEs, Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024), Change in safety laboratory values and vital signs, Change in ECG parameters, Plasma concentrations of RO7795081

Countries

Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026