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

June 2, 2026 updated by: Eli Lilly and Company

A Phase 2, 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 Bipolar Disorder (RENEW-Bipolar-1)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • ABB, Argentina, C1199ABB
        • Not yet recruiting
        • Hospital Italiano de Buenos Aires
        • Principal Investigator:
          • José Faccioli
      • Buenos Aires, Argentina, C1128AAF
        • Not yet recruiting
        • Mautalen Salud e Investigación
        • Contact:
          • Phone Number: 541145143400
        • Principal Investigator:
          • Bibiana Saravia
      • Buenos Aires, Argentina, C1023AAB
        • Not yet recruiting
        • STAT Research S.A.
        • Contact:
          • Phone Number: + 5491132613392
        • Principal Investigator:
          • Juan Ingelmo
      • Buenos Aires, Argentina, 1058
        • Recruiting
        • Centro Neurobiológico y de Estrés Traumático (CENydET)
        • Contact:
          • Phone Number: +5411 4313 4916
        • Principal Investigator:
          • Enrique Kuper
      • Buenos Aires, Argentina, 1405
        • Recruiting
        • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
        • Contact:
          • Phone Number: +5491156257810
        • Principal Investigator:
          • Luis Mosca
      • Córdoba, Argentina, X5003DCE
        • Not yet recruiting
        • Instituto Médico DAMIC
        • Contact:
          • Phone Number: +5493517352774
        • Principal Investigator:
          • Gerardo Garcia Bonetto
      • Córdoba, Argentina, X5004AOA
        • Not yet recruiting
        • Instituto Kremer
        • Principal Investigator:
          • TAMARA YERCOVICH
      • Córdoba, Argentina, X5006CBI
        • Not yet recruiting
        • Centro Medico Luquez
        • Contact:
          • Phone Number: +5493517481586
        • Principal Investigator:
          • Juan Luquez
      • La Plata, Argentina, 1904
        • Not yet recruiting
        • Global Psy Asociacion Civil
        • Principal Investigator:
          • Hernan Alessandria
      • Mendoza, Argentina, 5500
        • Not yet recruiting
        • Fundación Scherbovsky
        • Contact:
          • Phone Number: +5492615799019
        • Principal Investigator:
          • Sebastián Rauek
      • Rosario, Argentina, 2000
        • Not yet recruiting
        • INECO Neurociencias Oroño
        • Principal Investigator:
          • Dario Tavolini
        • Contact:
          • Phone Number: 5493416154466
      • Santiago del Estero, Argentina, 4200
        • Not yet recruiting
        • Clinica El Jardin
        • Contact:
          • Phone Number: +5493854027710
        • Principal Investigator:
          • Gaston Noriega
  • Brazil
      • Brasília, Brazil, 72145-450
        • Not yet recruiting
        • Chronos Pesquisa Clinica
        • Contact:
          • Phone Number: +55 61 98208-4248
        • Principal Investigator:
          • Monique Scalco
      • Campinas, Brazil, 13060-080
        • Not yet recruiting
        • Instituto de Pesquisa Clinica de Campinas
        • Principal Investigator:
          • Alexandre Comandule
      • Marília, Brazil, 17504-072
        • Not yet recruiting
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Contact:
          • Phone Number: 5511944404464
        • Principal Investigator:
          • Fernanda Guimarães
      • Rio de Janeiro, Brazil, 22270-060
        • Not yet recruiting
        • Ruschel Medicina e Pesquisa Clínica
        • Contact:
          • Phone Number: 55 21 35979708
        • Principal Investigator:
          • Sandra Ruschel
      • São Bernardo do Campo, Brazil, 09726-150
        • Not yet recruiting
        • Facili Centro Integrado de Psiquiatria
        • Contact:
          • Phone Number: +55 11 99399-0508
        • Principal Investigator:
          • Cintia de Azevedo Marques Périco
      • São Paulo, Brazil, 01228-000
        • Not yet recruiting
        • CPQuali Pesquisa Clínica
        • Contact:
          • Phone Number: +55 (11) 2776-6801
        • Principal Investigator:
          • Moacyr Rosa
      • São Paulo, Brazil, 01236030
        • Not yet recruiting
        • BR Trials - Ensaios Clinicos e Consultoria
        • Contact:
          • Phone Number: 1126722734
        • Principal Investigator:
          • Acioly Lacerda
      • São Paulo, Brazil, 04020-060
        • Not yet recruiting
        • Clinica Viver - Centro de Desospitalizacao Humana
        • Contact:
          • Phone Number: +55 11 99892-9840
        • Principal Investigator:
          • CLAUDIANE DALTIO
      • Valinhos, Brazil, 13271-130
        • Not yet recruiting
        • A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
        • Principal Investigator:
          • Caroline da Silva
  • China
      • Changsha, China, 410007
        • Recruiting
        • The Second People's Hospital of Hunan Province
        • Principal Investigator:
          • Xuhui Zhou
      • Hangzhou, China, 310000
        • Recruiting
        • The Seventh People's Hospital of Hangzhou
        • Principal Investigator:
          • Tao Li
      • Huzhou, China, 313000
        • Recruiting
        • 3rd People's Hospital of Huzhou
        • Principal Investigator:
          • Xiaocong Fei
      • Jinan, China, 250012
        • Recruiting
        • Shangdong Mental Health Center
        • Principal Investigator:
          • Mengmeng Sun
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Principal Investigator:
          • Xiaohua Liu
      • Shanghai, China, 200065
        • Recruiting
        • Shanghai Tongji Hospital
        • Principal Investigator:
          • Yuan Shen
      • Shijiazhuang, China, 050031
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Principal Investigator:
          • Cuixia An
      • Tianjin, China, 300022
        • Recruiting
        • Tianjin Anding Hospital
        • Principal Investigator:
          • Lina Wang
      • Xiamen, China, 361012
        • Recruiting
        • Xiamen Xianyue Hospital
        • Principal Investigator:
          • Lei Shi
      • Zhumadian, China, 463000
        • Recruiting
        • Zhumadian Psychiatric Hospital
        • Principal Investigator:
          • Jingli Wang
  • India
      • Aurangabad, India, 431001
        • Recruiting
        • Galaxy Superspeciality Hospital
        • Principal Investigator:
          • Amol Deshmukh
      • Belgavi, India, 590019
        • Not yet recruiting
        • Belagavi Institute of Medical Sciences - Belagavi
        • Principal Investigator:
          • Chandra Shekhar TR
      • Bhopal, India, 462024
        • Not yet recruiting
        • All India Institute of Medical Sciences (AIIMS) - Bhopal
        • Principal Investigator:
          • Tamonud Modak
      • Chhatrapati Sambhajinagar, India, 431005
        • Recruiting
        • Society for Psychiatric Update and Research
        • Contact:
          • Phone Number: +91-9823012123
        • Principal Investigator:
          • Chinmay Barhale
      • Dehradun, India, 248008
        • Not yet recruiting
        • Graphic Era Institute of Medical Sciences and Hospital
        • Principal Investigator:
          • Jeetpal Singh Rana
      • Dharwad, India, 580008
        • Not yet recruiting
        • Dharwad Institute Of Mental Health And Neurosciences
        • Principal Investigator:
          • Srinivas Kosgi
      • Lucknow, India, 226010
        • Not yet recruiting
        • Dr. Ram Manohar Lohia Institute of Medical Sciences
        • Principal Investigator:
          • Abdul Qadir Jilani
      • Lucknow, India, 226020
        • Not yet recruiting
        • Career Institute of Medical Sciences and Hospital - Lucknow
        • Principal Investigator:
          • Abbas Mehdi
      • Mysore, India, 570001
        • Not yet recruiting
        • Mysore Medical College
        • Contact:
          • Phone Number: 9633254370
        • Principal Investigator:
          • Narendra M.S.
      • Nashik, India, 422101
        • Not yet recruiting
        • Assured Care Plus Hospital
        • Principal Investigator:
          • Nakul Vanjari
      • Pune, India, 411057
        • Recruiting
        • Lifepoint Multispeciality Hospital
        • Principal Investigator:
          • Nitin Dalaya
      • Tiruchirappalli, India, 620002
        • Not yet recruiting
        • Sowmanasya Hospital and Institute of Psychiatry
        • Principal Investigator:
          • Gopalakrishnan Ganesan
      • Varanasi, India, 221005
        • Not yet recruiting
        • Deva Institute Of Healthcare Research
        • Contact:
          • Phone Number: +91-9935571052
        • Principal Investigator:
          • Venu Jhanwar
  • Japan
      • Chikugo, Japan, 833-0041
        • Recruiting
        • Uematsu Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ken Uematsu
      • Chiyoda City, Japan, 101-0051
        • Not yet recruiting
        • Jimbocho Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Tada
      • Fukushima, Japan, 960-8053
        • Not yet recruiting
        • Horikoshi Mental Somatic Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sho Horikoshi
      • Iruma, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Matsuo
      • Karatsu, Japan, 847-0031
        • Not yet recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Taro Shindo
      • Kumamoto, Japan, 862-0956
        • Not yet recruiting
        • Suizenji Life Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomohiko Matsuo
      • Kure, Japan, 737-0023
        • Recruiting
        • Kure Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Wataru Omori
      • Kurume, Japan, 830-0033
        • Not yet recruiting
        • Hirota Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Susumu Hirota
      • Kōtō City, Japan, 135-0047
        • Recruiting
        • Monzen-nakacho Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Junpei Sekiya
      • Sagamihara, Japan, 252-0303
        • Recruiting
        • Yutaka Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hideo Muraoka
      • Shibuya-ku, Japan, 151-0053
        • Recruiting
        • Maynds Tower Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Nobutoshi Kariya
      • Tokyo, Japan, 162-0843
        • Recruiting
        • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Seiji Hongo
      • Toshima City, Japan, 170-0013
        • Recruiting
        • Ikebukuro Olive Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sachie Matsushima
      • Yamagata, Japan, 990-0045
        • Not yet recruiting
        • Yamagata Sakuracho Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Nobuhiro Yokokawa
      • Yokohama, Japan, 220-0023
        • Recruiting
        • Miki Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazuhira Miki
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Not yet recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Rafael Fernández
      • Guadalajara, Mexico, 44650
        • Not yet recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
        • Principal Investigator:
          • Aura Garcia Aguilar
      • Mazatlán, Mexico, 82103
        • Not yet recruiting
        • B&B Investigaciones Medicas S.C.
        • Contact:
          • Phone Number: 52 669 146 3603
        • Principal Investigator:
          • GABRIEL BERNAL
      • Mexico City, Mexico, 04100
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • ARACELI MARTINEZ-ESTRADA
      • Mexico City, Mexico, 04100
        • Not yet recruiting
        • Ketamine Clinic México
        • Contact:
          • Phone Number: 55 15454240
        • Principal Investigator:
          • MANUEL RUIZ FLORES
      • Morelia, Mexico, 58260
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • Misael Tapia Orozco
      • Mérida, Mexico, 97070
        • Not yet recruiting
        • Medical Care and Research SA de CV
        • Principal Investigator:
          • Enrique Lara González
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • Recruiting
        • SCB Research Center
        • Principal Investigator:
          • William Julio
        • Contact:
          • Phone Number: (787) 798-4592
  • United States
    • California
      • Orange, California, United States, 92866
        • Recruiting
        • ATP Clinical Research
        • Principal Investigator:
          • Gustavo Alva
        • Contact:
          • Phone Number: 949-354-5353
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University School of Medicine
        • Contact:
          • Phone Number: 203-932-5711
        • Principal Investigator:
          • Mohini Ranganathan
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Aga Clinical Trials
        • Principal Investigator:
          • WILSON CUEVA
        • Contact:
          • Phone Number: 3058196990 X 1
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Accel Research Sites - Maitland Clinical Research Unit
        • Contact:
          • Phone Number: 386-785-2400
        • Principal Investigator:
          • Andrea Marraffino
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research - Maitland
        • Principal Investigator:
          • Sejal Patel
      • Miami Lakes, Florida, United States, 33016-1518
        • Recruiting
        • Floridian Clinical Research, LLC
        • Contact:
          • Phone Number: 305-330-9977
        • Principal Investigator:
          • Hortensia Valeron
      • Naples, Florida, United States, 34116
        • Recruiting
        • CLA Research
        • Contact:
          • Phone Number: 239-837-8818
        • Principal Investigator:
          • Evelia Iglesias
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research - Orlando
        • Principal Investigator:
          • Jorel Martinez
      • Weston, Florida, United States, 33331
        • Recruiting
        • Encore Medical Research - Weston
        • Contact:
          • Phone Number: 954-777-8827
        • Principal Investigator:
          • Luis Marchany Alfonso
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Principal Investigator:
          • Elyssa Barron
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Recruiting
        • Covenant Medical Center
        • Principal Investigator:
          • NICHOLAS GOETSCH
        • Contact:
          • Phone Number: 319-272-2112
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • CBH Health
        • Principal Investigator:
          • Elia Acevedo Diaz
        • Contact:
          • Phone Number: 301-251-4702
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Elixia MA
        • Principal Investigator:
          • Susan Smiga
        • Contact:
          • Phone Number: 413-305-1142
      • Watertown, Massachusetts, United States, 02472
        • Recruiting
        • Adams Clinical Watertown
        • Principal Investigator:
          • Dyanna Domilici
        • Contact:
          • Phone Number: 617-744-8542
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine: University of Pennsylvania Health System
        • Principal Investigator:
          • yvette sheline
    • Texas
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Jawad Riaz
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research - Richardson
        • Contact:
          • Phone Number: 214-396-4844
        • Principal Investigator:
          • Scott Bartley
    • Utah
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Alpine Research Organization
        • Principal Investigator:
          • Michael Roundy
        • Contact:
          • Phone Number: 801-928-3292
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Re:Cognition Health
        • Principal Investigator:
          • Scott Williams
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Phone Number: 425-453-0404
        • Principal Investigator:
          • Wisam Al jumaili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II

  • 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
  • Are on stable standard of care medication for bipolar disorder

Exclusion Criteria:

  • Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:

    • schizophrenia or other psychotic disorder
    • borderline personality disorder, or
    • any eating disorder

  • Have type 1 diabetes mellitus, or a history of

    • ketoacidosis, or
    • hyperosmolar state or coma
  • Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
  • Are actively suicidal and or deemed to be at 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneous (SC) + SoC.
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031
Experimental: Brenipatide Dose 2 .
Brenipatide administered subcutaneous (SC) + SoC.
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031
Placebo Comparator: Placebo
Placebo administered SC + SoC.
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
Time Frame: Randomization up to at least 6 months
Randomization up to at least 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time Frame: Baseline, up to at least 6 months
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
Baseline, up to at least 6 months
Change from Baseline in Young Mania Rating Scale (YMRS) Total Score
Time Frame: Baseline, up to at least 6 months
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
Baseline, up to at least 6 months
Change from Baseline in Patient Rated Outcome as Measured by Patient's Global Impression of Severity (PGI-S)
Time Frame: Baseline, up to at least 6 months
Baseline, up to at least 6 months
Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2
Time Frame: Baseline, up to at least 6 months
Baseline, up to at least 6 months
Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 and on an Atypical Antipsychotic
Time Frame: Baseline, up to at least 6 months
Baseline, up to at least 6 months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time Frame: Baseline, up to at least 6 months
Baseline, up to at least 6 months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies
Time Frame: Baseline, up to at least 6 months
Baseline, up to at least 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27365
  • J2S-MC-GZMJ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

Rare Diseases

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Dietary Supplements

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