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NCT Number: NCT06749795

LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)

A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, Poland

About this study

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged 18 to 65 years (inclusive) at Screening.
  • Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)

Exclusion criteria

  • Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
  • History of a condition associated with significant immunosuppression, or chronic administration (> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).

Treatment and study plan

LIV001

Drug

Orally administered for 8 weeks

Placebo

Drug

Orally administered for 8 weeks

Primary outcomes

  1. Number of subjects with adverse events (AEs)

    Time frame: Baseline through Study Completion (Week 12).

  2. Number of subjects with clinical laboratory abnormalities

    Time frame: Baseline through Study Completion (Week 12).

  3. Number of subjects with changes in the 12-lead electrocardiogram (ECG)

    Time frame: Baseline through Study Completion (Week 12).

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Hyun-Ja Ko, Doctor of Philosophy

CONTACT

[email protected]

+82-31-8065-8216

Sponsors and collaborators

Lead sponsor

Liveome Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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