In short
RO7795068 is an investigational protein-based substance being studied for weight management in people with obesity or overweight. Two authorised Phase 3 trials are evaluating whether it reduces body weight compared with placebo over 72 weeks, one including 2,000 participants without type 2 diabetes and another with 1,602 participants who have the condition. The substance is developed by F. Hoffmann-La Roche Ltd and has no marketing authorisation in these records.
Key points
- Phase 3 trials are evaluating RO7795068 in obesity or overweight, with and without type 2 diabetes.
- The larger trial enrols 2,000 participants without type 2 diabetes.
- A second trial enrols 1,602 participants with obesity or overweight and type 2 diabetes.
- Both trials measure the percent change in body weight from baseline at Week 72.
- RO7795068 is an investigational substance with no marketing authorisation in these records.
- The substance is a protein-based solution for injection.
What is RO7795068?
RO7795068 is an investigational protein-based substance being developed for weight management. Its full chemical name is N-[2-(3-CYANO-5-FLUOROPHENYL)-2-METHYL-1-OXOPROPYL]-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-[N-(19-CARBOXY-1-OXONONADECYL)-L-GAMMA-GLUTAMYL-2-[2-(2-AMINOETHOXY)ETHOXY]ACETYL-2-[2-(2-AMINOETHOXY)ETHOXY]ACETYL]-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE. The substance is registered in the EU Clinical Trials Information System (CTIS) under the product name RO7795068 and is supplied by F. Hoffmann-La Roche Ltd. It has no marketing authorisation in these product records, meaning it is still an investigational substance.
How does RO7795068 work?
The mechanism of action of RO7795068 is not described in the trial registry records. The two authorised trials are designed to evaluate its effect on weight management compared with placebo, but the registry data do not state which molecular target the substance acts on.
Which conditions is RO7795068 being studied for?
- Obesity or overweight without type 2 diabetes — a Phase 3 trial is testing whether RO7795068 helps people with excess body weight who do not have type 2 diabetes to lose weight over 72 weeks.
- Obesity or overweight and type 2 diabetes — a second Phase 3 trial is evaluating the substance in people who have both excess body weight and type 2 diabetes, a condition where blood sugar levels are too high.
How is RO7795068 given?
RO7795068 is formulated as a solution for injection. The registry records do not specify the route of administration or the dosing schedule used in the trials.
What do the clinical trials show?
Two authorised Phase 3 trials are investigating RO7795068 in obesity or overweight. The first trial enrols 2,000 participants without type 2 diabetes, while the second enrols 1,602 participants with obesity or overweight and type 2 diabetes. Both are interventional studies comparing RO7795068 with placebo. The primary outcome in each trial is the percent (%) change from baseline in body weight at Week 72, which measures how much body weight participants lose over 72 weeks compared with their starting weight. The trials are authorised, meaning they have received approval to proceed, but no results are reported in the registry records at this time.