A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

Официальное название

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C

Обзор

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Вмешательства

• Препарат LY3537031
  Administered SC.
• Препарат Placebo
  Administered SC.

Первичные конечные точки

• Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks [Срок оценки: Week 9 to 16]

Вторичные конечные точки (2)

• Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks [Срок оценки: Week 9 to 16]
• Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks [Срок оценки: Week 9 to 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Del Sol Research Management - Mesa — Mesa
• Smart Cures Clinical Research — Anaheim
• Om Research LLC — Lancaster
• United Medical Doctors - Los Alamitos — Los Alamitos
• Encore Medical Research — Hollywood
• Springfield Clinic - First — Springfield
• Gastroenterology Health Partners — New Albany
• Gastroenterology Health Partners — Louisville
• … и ещё 6 центров

Китай · 12 центров

• Binzhou Medical University Hospital — Binzhou
• Sichuan Provincial People's Hospital — Чэнду
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Zhejiang Hospital of Traditioal Chinese Medicine — Ханчжоу
• The Second Affiliated Hospital of University of South China — Hengyang
• Huizhou Central People's Hospital — Huizhou
• Huzhou Central Hospital — Huzhou
• Meihekou Central Hospital — Meihekou
• … и ещё 4 центра

Бельгия · 10 центров

• Sint Vincentius Ziekenhuis — Antwerp
• AZ Sint-Lucas — Bruges
• UZ Brussel — Brussels
• Antwerp University Hospital — Edegem
• AZ Maria Middelares — Ghent
• AZ Sint-Lucas — Ghent
• UZ Gent — Ghent
• UZ Leuven — Leuven
• … и ещё 2 центра

Мексика · 8 центров

• Scientia Investigacion Clinica Tj — Ciudad de Tijuana
• Centro de Investigación y Gastroenterología - S.C. — Mexico City
• Centro de Investigación Clinica Chapultepec — Mexico City
• Hospital Juarez de Mexico — Mexico City
• Kohler & Milstein Research S.A. De C.V. — Mérida
• CIMAB SA de CV — Torreón
• FAICIC S. de R.L. de C.V. — Veracruz
• Núcleo de Investigación Médica Sur de Guadalajara — Zapopan

Испания · 8 центров

• Hospital Universitari Vall d'Hebron — Barcelona
• EAP Osona Sud - Alt Congost S.L.P — Centelles
• Hospital Universitario Virgen Nieves — Granada
• Hospital Clinico San Carlos — Madrid
• Hospital Universitario Puerta de Hierro Majadahonda — Madrid
• Hospital Costa del Sol — Marbella
• Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca
• Clínica Gaias - Santiago — Santiago de Compostela

Великобритания · 8 центров

• Cheadle Community Hospital — Cheadle
• HMC Health Group - Meadows Centre for Health — Hounslow
• EMS Healthcare — Macclesfield
• Royal Victoria Infirmary — Newcastle upon Tyne
• Newquay Health Centre — Newquay
• Woodstock Bower Surgery — Rotherham
• Brockwood Medical Practice — Surrey
• King's Mill Hospital — Sutton in Ashfield

Канада · 5 центров

• Bluewater Clinical Research Group Inc. — Sarnia
• Scarborough Center for Inflammatory Bowel Disease — Scarborough
• ClinSurge Research - LMC Scarborough / Malvern Medical Centre — Scarborough
• Stouffville Medical Research Institute Inc. — Stouffville
• Canadian Phase Onward — Toronto

Япония · 5 центров

• Tokyo-Eki Center-building Clinic — Chūōku
• Tokai University Hospital — Isehara
• Aono Clinic — Kobe
• Sapporo Odori Endoscope Clinic — Sapporo
• Nishi-Shinjuku Kisaragi Clinic — Shinjuku-Ku

Идентификаторы

NCT: NCT07545772 · 27821 · J2S-MC-GZMT · 2025-524974-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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