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Study of Choline Chloride for Intestinal Failure

This study is testing Choline Chloride for Injection in adolescents and adults (age 12 and older) who have intestinal failure and receive long-term parenteral support (nutrition given intravenously). The goal is to see how safe and effective Choline Chloride for Injection is compared to a placebo (an inactive substance). Researchers are looking at how the body processes Choline Chloride for Injection (pharmacokinetics, or PK) during the first eight weeks. This study aims to help people with choline deficiency and liver injury. The study plans to enroll 129 participants, but its current status is unclear.

Study design
This is a Phase 2b/3 randomized study with an open-label dose-selection phase and a double-blind, placebo-controlled phase, followed by open-label extensions. It plans to enroll 129 participants.
What's involved
Participants will be enrolled in one of two parts, each followed by an open-label extension period of about a year. Plasma free choline will be measured during Week 1 and Week 8 visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately a year during the open-label extension period after each part of the study.

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NCT06910943

Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support

Recruiting
PHASE2Ages 12+InterventionalTreatment
Protara Therapeutics
~129 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Choline Chloride for InjectionPlacebo

At a glance

Recruiting sites
14 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Open-Label Dose-Selection Phase: PK of plasma free choline (Cmax) during Week 1 and Week 8 Visits
Measured over Week 1 to Week 8
+9 more outcomes measured

Conditions

Choline Deficiency
Liver Injury

Explore related trials

Choline deficiencyIntestinal Failure

Where it's being run

18 sites across 13 states
France3
Denmark2
Germany2
Poland2
Colorado1
Florida1
Illinois1
Nebraska1

Study leadership

  • Chief Scientific Operations Officer · STUDY_DIRECTOR · Protara Therapeutics

Who to contact

Chief Scientific Operations Officer
[email protected]
16468440337
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Eligibility criteria

Inclusion

Male or female 12 years of age or older at the time of signing the informed consent
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry
Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable PS at time of screening and for the duration of the study; Note: Long-Term PS = Participant must have been receiving PS for at least 6 months prior to screening and requiring PS at least 3 times per week
Females of childbearing potential must have a negative urine pregnancy test at screening

Exclusion

Participants taking steatogenic medications or any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to signing consent
Evidence of systemic active infection at the time of dosing
Participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study
Participants unwilling to limit alcohol intake to no more than 20/g a day for 24 hours prior to their screening visit and for the duration of the study
Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer)
Clinically significant renal disease
Low B12 or low serum folic acid levels that are less than the normal range
Participants with severe hepatic impairment, defined as Child-Turcotte-Pugh (CTP) Class C (score ≥10) at screening.

What this trial measures

  • Open-Label Dose-Selection Phase: PK of plasma free choline (Cmax) during Week 1 and Week 8 VisitsWeek 1 to Week 8

    Cmax = maximum concentration

  • Open-Label Dose-Selection Phase: Open-Label Dose-Selection Phase: PK of plasma free choline (Tmax) during Week 1 and Week 8 VisitsWeek 1 to Week 8

    Tmax = time of maximum concentration

  • Open-Label Dose-Selection Phase: PK of plasma free choline (AUC(0-TAU)) during Week 1 and Week 8 VisitsWeek 1 to Week 8

    AUC = area under the curve, AUC(0-TAU) = AUC at end of dosing

  • Open-Label Dose-Selection Phase: Change from Baseline in plasma free choline concentrations at Week 8Week 1 to Week 8
  • Open-Label Dose-Selection Phase and Double-Blind, Placebo-Controlled Phase, Open-Label Extension Phase: Incidence and severity of TEAEs Incidence of TESAEsWeek 1 to Week 64

    TEAE = treatment emergent adverse event, TESAE = treatment emergent serious adverse event

  • Double-Blind, Placebo-Controlled Phase: Change from Baseline in peak plasma free choline concentrations (Cmax) at Week 8 in participants receiving Choline Chloride for Injection versus PlaceboWeek 1 to Week 8

    Tmax = time of maximum concentration

  • Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase: Percentage of participants with plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 64Week 64
  • Open-Label Extension Phase: Percentage of participants maintaining plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 8 and Week 64 (ie, both timepoints)Week 8 to Week 64
  • Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % with plasma free choline concentrations of ≥9.5 nmol/mL at Week 64Week 1 to Week 64
  • Open-Label Extension Phase: Participants from Double-Blind Placebo-Controlled Phase: % maintaining plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 8, Week 24 and Week 64 for participants who previously received Choline Chloride for InjectionWeek 8 to Week 64