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NCT07410507: RENEW-Scz-1

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Recruiting now Phase 2 Last updated 2 June 2026
What this trial tests

Phase 2 trial testing Brenipatide in Schizophrenia in 450 participants. Currently enrolling.

Timeline
10 February 2026
Primary endpoint
1 November 2027
1 November 2027

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment450
Start date10 February 2026
Primary completion1 November 2027
Estimated completion1 November 2027
Sites102 locations across United States, Argentina, Brazil, China, India, Japan, Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 55, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07410507.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing