assignment
Not Recruiting

A Phase I Study to Evaluate the Safety and Pharmacokinetics of RO7795074 in Overweight or Obese Healthy Volunteers

Trial ID
2025-521888-13-00
Protocol
BP45861

Trial statistics

location_city
1
research site
public
1
country
medical_information
2
diseases

Diseases & Conditions

Objectives

The primary objective of this study is to evaluate the safety and absorption of different administration forms of RO7795074 in individuals with overweight or obesity. Assessing these parameters is critical for determining the potential suitability of this novel compound for the management of type 1 diabetes. 4, 6

Participants

This clinical trial involves 16 healthy volunteers. The study population consists of both male and female participants within the 18-44 years age range. Included individuals are characterized as being overweight or obese while remaining otherwise healthy. The sponsor did not provide specific information regarding the selection process or lifestyle considerations.

Plans and Procedures

This Phase 3 clinical trial utilizes a design to investigate the safety and absorption of different administration forms of RO7795074, a novel compound intended for the potential treatment of Type 1 Diabetes. The study involves participants who are overweight or obese but otherwise healthy. The research methodology includes a screening visit to assess eligibility, followed by scheduled follow-up visits to monitor clinical outcomes and physiological responses. The sequence of procedures concludes with an end-of-study visit. Total participant involvement is determined by the clinical requirements of the protocol, and early termination may occur based on specific clinical conditions or safety criteria. The estimated duration for the study period is from December 2025 to April 2026.

Treatment

Please provide the source data containing the details of the medications, dosages, and administration protocols. Once the data is provided, the description will be generated according to the specified technical and formatting requirements.

Efficacy

The assessment of efficacy in this Phase 3 clinical trial is focused on individuals with overweight or obesity. No specific parameters, measurement methods, or assessment tools were provided in the source documentation.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
The Netherlands The NetherlandsNot Recruiting09 Dec 2025
Netherlands Netherlands72

Sites & Investigators

Conditions Studied in This Trial