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Предстои набиране Фаза 2 NCT07545772

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Irritable Bowel Syndrome Constipation

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
LY3537031
DRUG
Placebo
DRUG
Места на провеждане 1
САЩ (1)
Gastroenterology Health Partners Loc. 1
Louisville , Kentucky
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
01.09.2027
Регистрационен номер
NCT07545772
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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