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New shot for stubborn constipation pain enters Mid-Stage trial

NCT ID NCT07545772

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 12 times

Summary

This study tests an injected drug called brenipatide in 342 adults with irritable bowel syndrome with constipation (IBS-C). Participants will receive either the drug or a placebo for about 35 weeks. The goal is to see if brenipatide safely reduces abdominal pain and improves bowel habits better than a dummy shot.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brenipatide (a drug injected under the skin)
What this could lead to
If it works, this could lead to a new treatment option that eases abdominal pain and improves bowel movements for people with IBS-C.
What could go wrong
This is an early Phase 2 trial, so the drug may not prove more effective than placebo. Side effects are still being studied, and results may not apply to all IBS-C patients.

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 342 people

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

Started

Apr 2026

Expected to finish

Sep 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: * Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7 * Based on the daily eDiary collection during the screening period: * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization Exclusion Criteria: * Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, mixed IBS, or unclassified IBS by the Rome IV criteria * Have a history of inflammatory or immune-mediated gastrointestinal disorders * Have a known clinically significant gastric emptying abnormality

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Conditions

The condition(s) this trial relates to.

constipation disorder irritable bowel syndrome

As listed by the trial registrant

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

Constipation Irritable bowel syndrome

How to take part

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

  1. The places running it

    70 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

  • AZ Delta vzw

    NOT_YET_RECRUITING

    Roeselare, 8800, Belgium

  • AZ Maria Middelares

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • AZ Sint-Lucas

    NOT_YET_RECRUITING

    Bruges, 8310, Belgium

  • AZ Sint-Lucas

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • Antwerp University Hospital

    NOT_YET_RECRUITING

    Edegem, 2650, Belgium

  • Aono Clinic

    RECRUITING

    Kobe, 657-0841, Japan

  • Binzhou Medical University Hospital

    RECRUITING

    Binzhou, 256603, China

  • Biopharma Informatic, LLC

    RECRUITING

    McAllen, Texas, 78503, United States

  • Bluewater Clinical Research Group Inc.

    RECRUITING

    Sarnia, N7T 4X3, Canada

  • Brockwood Medical Practice

    RECRUITING

    Surrey, RH3 7NJ, United Kingdom

  • CIMAB SA de CV

    NOT_YET_RECRUITING

    Torreón, 27000, Mexico

  • Canadian Phase Onward

    RECRUITING

    Toronto, M3J 0K2, Canada

  • Centro de Investigación Clinica Chapultepec

    RECRUITING

    Mexico City, 04100, Mexico

  • Centro de Investigación y Gastroenterología - S.C.

    RECRUITING

    Mexico City, 03330, Mexico

  • Cheadle Community Hospital

    RECRUITING

    Cheadle, ST10 1NS, United Kingdom

  • ClinSurge Research - LMC Scarborough / Malvern Medical Centre

    RECRUITING

    Scarborough, M1R 0B1, Canada

  • Clinical Chc Montlégia

    NOT_YET_RECRUITING

    Liège, 4000, Belgium

  • Clínica Gaias - Santiago

    RECRUITING

    Santiago de Compostela, 15702, Spain

  • Del Sol Research Management - Mesa

    RECRUITING

    Mesa, Arizona, 85206, United States

  • EAP Osona Sud - Alt Congost S.L.P

    RECRUITING

    Centelles, 08540, Spain

  • EMS Healthcare

    RECRUITING

    Macclesfield, SK10 4TF, United Kingdom

  • Encore Medical Research

    RECRUITING

    Hollywood, Florida, 33024, United States

  • FAICIC S. de R.L. de C.V.

    RECRUITING

    Veracruz, 91900, Mexico

  • GI Alliance-Webster

    RECRUITING

    Webster, Texas, 77598, United States

  • Gastroenterology Health Partners

    RECRUITING

    New Albany, Indiana, 47150, United States

  • Gastroenterology Health Partners

    RECRUITING

    Louisville, Kentucky, 40218, United States

  • HMC Health Group - Meadows Centre for Health

    RECRUITING

    Hounslow, TW4 7NR, United Kingdom

  • Hospital Clinico San Carlos

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • Hospital Costa del Sol

    NOT_YET_RECRUITING

    Marbella, 29603, Spain

  • Hospital Juarez de Mexico

    NOT_YET_RECRUITING

    Mexico City, 07760, Mexico

  • Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    NOT_YET_RECRUITING

    Madrid, 28222, Spain

  • Hospital Universitario Virgen Nieves

    NOT_YET_RECRUITING

    Granada, 18014, Spain

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    NOT_YET_RECRUITING

    Salamanca, 37007, Spain

  • Huizhou Central People's Hospital

    RECRUITING

    Huizhou, 516001, China

  • Huzhou Central Hospital

    RECRUITING

    Huzhou, 313000, China

  • King's Mill Hospital

    RECRUITING

    Sutton in Ashfield, NG17 4JL, United Kingdom

  • Kohler & Milstein Research S.A. De C.V.

    NOT_YET_RECRUITING

    Mérida, 97070, Mexico

  • Meihekou Central Hospital

    RECRUITING

    Meihekou, 135000, China

  • New York Gastroenterology Associates

    RECRUITING

    New York, New York, 10075, United States

  • Newquay Health Centre

    RECRUITING

    Newquay, TR7 1RU, United Kingdom

  • Nishi-Shinjuku Kisaragi Clinic

    RECRUITING

    Shinjuku-Ku, 160-0023, Japan

  • Núcleo de Investigación Médica Sur de Guadalajara

    RECRUITING

    Zapopan, 45070, Mexico

  • Ohio Gastroenterology

    RECRUITING

    Columbus, Ohio, 43202, United States

  • Om Research LLC

    RECRUITING

    Lancaster, California, 93534, United States

  • Quzhou People's Hospital

    RECRUITING

    Quzhou, 324000, China

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Sapporo Odori Endoscope Clinic

    RECRUITING

    Sapporo, 060-0042, Japan

  • Scarborough Center for Inflammatory Bowel Disease

    RECRUITING

    Scarborough, M1B 3V4, Canada

  • Scientia Investigacion Clinica Tj

    RECRUITING

    Ciudad de Tijuana, 22105, Mexico

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, 610072, China

  • Sint Vincentius Ziekenhuis

    NOT_YET_RECRUITING

    Antwerp, 2018, Belgium

  • Smart Cures Clinical Research

    RECRUITING

    Anaheim, California, 92806, United States

  • Southern Star Research Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Springfield Clinic - First

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Stouffville Medical Research Institute Inc.

    RECRUITING

    Stouffville, L4A 1H2, Canada

  • Taian City Central Hospital

    RECRUITING

    Taian, 271000, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, 510080, China

  • The Second Affiliated Hospital of University of South China

    RECRUITING

    Hengyang, 421200, China

  • Tokai University Hospital

    RECRUITING

    Isehara, 259-1193, Japan

  • Tokyo-Eki Center-building Clinic

    RECRUITING

    Chūōku, 103-0027, Japan

  • UZ Brussel

    NOT_YET_RECRUITING

    Brussels, 1090, Belgium

  • UZ Gent

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

  • United Medical Doctors - Los Alamitos

    RECRUITING

    Los Alamitos, California, 90720, United States

  • University Gastroenterology

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Woodstock Bower Surgery

    RECRUITING

    Rotherham, S61 1AH, United Kingdom

  • Xianning Central Hospital

    RECRUITING

    Xianning, 437100, China

  • Yichun People's Hospital

    RECRUITING

    Yichun, 336000, China

  • Zhejiang Hospital of Traditioal Chinese Medicine

    RECRUITING

    Hangzhou, 310006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.