A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Brief summary (registry, in English)

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

What you commit to

• Study type: Interventional · Phase 2
• Planned participants: 400
• From 24 Nov 2025 to the primary completion date, 30 Nov 2027
• 87 sites in 8 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (87)

Sites in registry order. Pick your city on the disease page to sort them by distance.