A Phase I Study to Evaluate the Safety, Absorption, and Elimination of RO7795081 in Subjects with Type 2 Diabetes and Overweight
- Trial ID
- 2025-522766-78-00
- Protocol
- BP46037
- Sponsor
- F. Hoffmann-La Roche AG
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the safety, absorption, and elimination of RO7795081. This investigation is clinically relevant to characterize the pharmacokinetic profile of the compound as a potential therapeutic agent for type 2 diabetes and weight control. 4, 6.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers. The cohort includes both males and females, including vulnerable populations. The participants fall within the age range represented by code 3.
Plans and Procedures
This Phase 3 clinical trial is designed to investigate the safety, absorption, and elimination of RO7795081, a novel compound intended for the treatment of type 2 diabetes and weight control. The research methodology follows a structured protocol involving several stages of evaluation. The process begins with a screening visit to assess eligibility. Subsequent follow-up visits are conducted to monitor the pharmacological profile and physiological responses to the compound. The sequence concludes with an end-of-study visit. The total duration of the study is estimated to occur between November 2025 and August 2026. Participation may be subject to early termination based on predefined clinical conditions or safety criteria.
Treatment
Efficacy
The provided source material does not contain information regarding the assessment of efficacy, specific parameters, endpoints, or methods used to evaluate clinical outcomes.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
The Netherlands | Not Recruiting | 24 Nov 2025 | — |
Netherlands | — | — | 16 |

