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RENEW-Scz-1

RecruitingPhase 2

A Study of Brenipatide in Adult Participants With Schizophrenia

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)

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

101

Recruiting sites

98

Estimated enrollment

450

Study population

Psychiatric (schizophrenia / bipolar / depression)

Eligibility highlights

-

Primary endpoint

•Body Weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07410507
Org study ID27366
Secondary IDJ2S-MC-GZMKEli Lilly and Company

Timeline

Milestones

Study start2026-02-10actual
Study first posted2026-02-13actual
Last update posted2026-10-07actual
Primary completion2027-11estimated (month precision)
Study completion2027-11estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Psychiatric (schizophrenia / bipolar / depression)

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Meet the diagnostic criteria of schizophrenia
•Are on a stable standard of care medication regimen for schizophrenia
•If the duration of illness is >6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
•Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
•Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
-self-inject study intervention store and use the provided study intervention as directed,
-maintain electronic or paper study diaries, as applicable, and
-complete the required questionnaires

Exclusion criteria

•Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
•Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
•Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
•Are actively suicidal or deemed to be a significant risk for suicide
•Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Weight & body composition
2
Safety / tolerability / PK
2
Other clinical outcomes
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)

Time frame:Baseline, Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5%

Time frame:Baseline up to 52 Weeks

threshold achievement, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

Time frame:Baseline up to Week 52

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Treatment-Emergent Anti-Drug Antibodies

Time frame:Baseline up to Week 52

event count, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Time to Relapse

Time frame:Randomization up to Week 52

time to event, event

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36

Time frame:Baseline, Week 36

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Patient Global Impression - Severity

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score

Time frame:Baseline, Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.