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New shot aims to keep bipolar symptoms at bay longer

NCT ID NCT07286175

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study tests whether adding the drug brenipatide to standard treatment can delay the return of bipolar symptoms compared to a placebo. About 400 adults with bipolar I or II will self-inject the study drug or placebo for at least 6 months. The main goal is to see how long it takes for symptoms to worsen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 3rd People's Hospital of Huzhou

    RECRUITING

    Huzhou, 313000, China

  • A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos

    RECRUITING

    Valinhos, 13271-130, Brazil

  • AGA Clinical Trials

    RECRUITING

    Hialeah, Florida, 33012, United States

  • ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Accel Research Sites - Maitland Clinical Research Unit

    RECRUITING

    Maitland, Florida, 32751, United States

  • Adams Clinical Watertown

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • All India Institute of Medical Sciences (AIIMS) - Bhopal

    NOT_YET_RECRUITING

    Bhopal, 462024, India

  • Alpine Research Organization

    RECRUITING

    Clinton, Utah, 84015, United States

  • Assured Care Plus Hospital

    RECRUITING

    Nashik, 422101, India

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • B&B Investigaciones Medicas S.C.

    RECRUITING

    Mazatlán, 82103, Mexico

  • BR Trials - Ensaios Clinicos e Consultoria

    RECRUITING

    São Paulo, 01236030, Brazil

  • Belagavi Institute of Medical Sciences - Belagavi

    RECRUITING

    Belgavi, 590019, India

  • CBH Health

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • CLA Research

    RECRUITING

    Naples, Florida, 34116, United States

  • CPQuali Pesquisa Clínica

    RECRUITING

    São Paulo, 01228-000, Brazil

  • Career Institute of Medical Sciences and Hospital - Lucknow

    RECRUITING

    Lucknow, 226020, India

  • Centro Médico Luquez

    RECRUITING

    Córdoba, X5006CBI, Argentina

  • Centro Neurobiológico y de Estrés Traumático (CENydET)

    RECRUITING

    Buenos Aires, 1058, Argentina

  • Centro de Investigacion Clinica Chapultepec

    RECRUITING

    Morelia, 58260, Mexico

  • Centro de Investigación Clinica Chapultepec

    RECRUITING

    Mexico City, 04100, Mexico

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    RECRUITING

    Marília, 17504-072, Brazil

  • Charter Research - Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Chronos Pesquisa Clínica

    RECRUITING

    Brasília, 72145-450, Brazil

  • Clinica El Jardin

    RECRUITING

    Santiago del Estero, 4200, Argentina

  • Clinica Viver - Centro de Desospitalizacao Humana

    RECRUITING

    São Paulo, 04020-060, Brazil

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    RECRUITING

    Guadalajara, 44650, Mexico

  • Covenant Medical Center

    RECRUITING

    Waterloo, Iowa, 50702, United States

  • Deva Institute Of Healthcare Research

    RECRUITING

    Varanasi, 221005, India

  • Dharwad Institute Of Mental Health And Neurosciences

    NOT_YET_RECRUITING

    Dharwad, 580008, India

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    RECRUITING

    Lucknow, 226010, India

  • Elixia MA

    RECRUITING

    Springfield, Massachusetts, 01103, United States

  • Encore Medical Research - Weston

    RECRUITING

    Weston, Florida, 33331, United States

  • Facili Centro Integrado de Psiquiatria

    RECRUITING

    São Bernardo do Campo, 09726-150, Brazil

  • Floridian Clinical Research, LLC

    RECRUITING

    Miami Lakes, Florida, 33016-1518, United States

  • Fundacion Scherbovsky

    RECRUITING

    Mendoza, 5500, Argentina

  • Galaxy Superspeciality Hospital

    RECRUITING

    Aurangabad, 431001, India

  • Global Psy Asociación Civil

    RECRUITING

    La Plata, 1904, Argentina

  • Graphic Era Institute of Medical Sciences and Hospital

    NOT_YET_RECRUITING

    Dehradun, 248008, India

  • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

    RECRUITING

    Tokyo, 162-0843, Japan

  • Hirota Clinic

    RECRUITING

    Kurume, 830-0033, Japan

  • Horikoshi Mental Somatic Clinic

    RECRUITING

    Fukushima, 960-8053, Japan

  • Hospital Italiano de Buenos Aires

    NOT_YET_RECRUITING

    ABB, C1199ABB, Argentina

  • INECO Neurociencias Oroño

    RECRUITING

    Rosario, 2000, Argentina

  • Ikebukuro Olive Mental Clinic

    RECRUITING

    Toshima City, 170-0013, Japan

  • Instituto Kremer

    RECRUITING

    Córdoba, X5004AOA, Argentina

  • Instituto Médico DAMIC

    RECRUITING

    Córdoba, X5003DCE, Argentina

  • Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

    RECRUITING

    Buenos Aires, 1405, Argentina

  • Instituto de Pesquisa clinica de Campinas

    RECRUITING

    Campinas, 13060-080, Brazil

  • Jimbocho Mental Clinic

    RECRUITING

    Chiyoda City, 101-0051, Japan

  • K2 Medical Research - Maitland

    RECRUITING

    Maitland, Florida, 32751, United States

  • Ketamine Clinic México

    RECRUITING

    Mexico City, 04100, Mexico

  • Kure Medical Center

    RECRUITING

    Kure, 737-0023, Japan

  • Lifepoint Multispeciality Hospital

    RECRUITING

    Pune, 411057, India

  • Mautalen Salud e Investigación

    RECRUITING

    Buenos Aires, C1128AAF, Argentina

  • Maynds Tower Mental Clinic

    RECRUITING

    Shibuya-ku, 151-0053, Japan

  • Medical Care and Research SA de CV

    RECRUITING

    Mérida, 97070, Mexico

  • Miki Mental Clinic

    RECRUITING

    Yokohama, 220-0023, Japan

  • Monzen-nakacho Mental Clinic

    RECRUITING

    Kōtō City, 135-0047, Japan

  • Mysore Medical College

    NOT_YET_RECRUITING

    Mysore, 570001, India

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Penn Medicine: University of Pennsylvania Health System

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Pillar Clinical Research - Richardson

    RECRUITING

    Richardson, Texas, 75080, United States

  • Rainbow and Sea Hospital

    RECRUITING

    Karatsu, 847-0031, Japan

  • Re:Cognition Health

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Revival Research Institute, LLC

    RECRUITING

    McKinney, Texas, 75071, United States

  • Ruschel Medicina e Pesquisa Clínica

    NOT_YET_RECRUITING

    Rio de Janeiro, 22270-060, Brazil

  • SCB Research Center

    RECRUITING

    Bayamón, 00961, Puerto Rico

  • Saitama Medical University Hospital

    RECRUITING

    Iruma, 350-0495, Japan

  • Scientia Investigacion Clinica S.C.

    RECRUITING

    Chihuahua City, 31203, Mexico

  • Shangdong Mental Health Center

    RECRUITING

    Jinan, 250012, China

  • Shanghai Mental Health Center

    RECRUITING

    Shanghai, 200030, China

  • Shanghai Tongji Hospital

    RECRUITING

    Shanghai, 200065, China

  • Society for Psychiatric Update and Research

    RECRUITING

    Chhatrapati Sambhajinagar, 431005, India

  • Sowmanasya Hospital and Institute of Psychiatry

    NOT_YET_RECRUITING

    Tiruchirappalli, 620002, India

  • Stat Research S.A.

    NOT_YET_RECRUITING

    Buenos Aires, C1023AAB, Argentina

  • Suizenji Life Clinic

    RECRUITING

    Kumamoto, 862-0956, Japan

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050031, China

  • The Second People's Hospital of Hunan Province

    RECRUITING

    Changsha, 410007, China

  • The Seventh People's Hospital of Hangzhou

    RECRUITING

    Hangzhou, 310000, China

  • Tianjin Anding Hospital

    RECRUITING

    Tianjin, 300022, China

  • Uematsu Mental Clinic

    RECRUITING

    Chikugo, 833-0041, Japan

  • Xiamen Xianyue Hospital

    RECRUITING

    Xiamen, 361012, China

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Yamagata Sakuracho Hospital

    RECRUITING

    Yamagata, 990-0045, Japan

  • Yutaka Clinic

    RECRUITING

    Sagamihara, 252-0303, Japan

  • Zhumadian Psychiatric Hospital

    RECRUITING

    Zhumadian, 463000, China

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