A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Official title

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Overview

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Interventions

• Drug Brenipatide
  Administered SC
• Drug Placebo
  Administered SC

Primary outcome measures

• Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD) [Time frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months]

Secondary outcome measures (11)

• Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 [Time frame: Baseline, Up to at Least 6 Months]
• Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Time frame: Baseline, Up to at Least 6 Months]
• Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score [Time frame: Baseline, Up to at Least 6 Months]
• Change from Baseline in Patient Global Impression of Severity (PGI-S) [Time frame: Baseline, Up to at Least 6 Months]
• Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score [Time frame: Baseline, Up to at Least 6 Months]
• Change from Baseline in Patient Rated Symptom and Disease Severity [Time frame: Baseline, Up to at least 6 months]
• Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score [Time frame: Baseline, Up to at Least 6 Months]
• Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic [Time frame: Baseline, Up to at Least 6 Months]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Time frame: Predose Up to at Least 6 Months]
• Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA) [Time frame: Baseline Up to at Least 6 Months]
• Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form [Time frame: Baseline, Up to at Least 6 Months]

Eligibility criteria

Inclusion criteria

• Meet the diagnostic criteria for major depressive disorder
• Are on a stable standard of care medication for major depressive disorder
• 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 blinded study intervention, as directed
• maintain electronic and paper study diaries, as applicable, and
• complete the required questionnaires

Exclusion criteria

• Have a lifetime history or current diagnosis of the following:

• schizophrenia or other psychotic disorder
• bipolar disorder
• borderline personality disorder, or
• any eating disorder.
• Have type 1 diabetes mellitus, or a history of

• ketoacidosis, or
• hyperosmolar state or coma.
• Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
• Are actively suicidal or deemed a significant risk for suicide
• Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 32 centers

• Accellacare - Moorpark — Moorpark
• ATP Clinical Research — Orange
• Yale University School of Medicine — New Haven
• Encore Medical Research — Hollywood
• K2 Medical Research - Maitland — Maitland
• Life Medical Research Group Corp — Miami Gardens
• Floridian Clinical Research, LLC — Miami Lakes
• CLA Research — Naples
• … and 24 more centers

Japan · 26 centers

Center list to be confirmed — check the primary protocol.

China · 20 centers

• Beijing Anding Hospital - Affiliated Capital University of Medical Science — Beijing
• Beijing HuiLongGuan Hospital — Beijing
• The Second People's Hospital of Hunan Province — Changsha
• The Fourth People's Hospital of Chengdu — Chengdu
• Guangzhou Brain Hospital — Guangzhou
• Peking University Sixth Hospital — Haidian District
• Hefei No.4 People's Hospital — Hefei
• 3rd People's Hospital of Huzhou — Huzhou
• … and 12 more centers

Canada · 14 centers

• Heritage Medical Research Clinic — Calgary
• Premier Clinical Trial Network — Hamilton
• Kelowna Health and Memory Centre — Kelowna
• Alpha Recherche Clinique - Lévis — Lévis
• Genge Partners — Montreal
• Dar Clinical Research - Ottawa — Ottawa
• Centre de Recherche Saint-Louis inc. — Québec
• Alpha Recherche Clinique — Québec
• … and 6 more centers

Brazil · 11 centers

• Hospital das Clínicas da UFMG — Belo Horizonte
• Trial Tech — Curitiba
• Clinilive — Maringá
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
• Hospital Universitário Onofre Lopes — Natal
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Facili Centro Integrado de Psiquiatria — São Bernardo do Campo
• CPQuali Pesquisa Clínica — São Paulo
• … and 3 more centers

United Kingdom · 10 centers

Center list to be confirmed — check the primary protocol.

Poland · 9 centers

Center list to be confirmed — check the primary protocol.

South Korea · 9 centers

Center list to be confirmed — check the primary protocol.

Spain · 9 centers

Center list to be confirmed — check the primary protocol.

Germany · 8 centers

Center list to be confirmed — check the primary protocol.

Mexico · 8 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 8 centers

Center list to be confirmed — check the primary protocol.

Australia · 7 centers

• NeuroCentrix — Carlton
• Lyell McEwin Hospital — Elizabeth Vale
• Barwon Health — Geelong
• Multidisciplinary Alfred Psychiatry Research Centre — Melbourne
• Paratus Clinical Research - Melbourne — Melbourne
• Toowoomba Hospital — Toowoomba
• Westmead Hospital — Westmead

Greece · 7 centers

Center list to be confirmed — check the primary protocol.

Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07412756 · 27363 · 2025-522308-25-00 · J2S-MC-GZMH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗