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RecruitingPhase 2/Phase 3

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

Protara Therapeutics · NCT06910943

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
129
US sites recruiting
6
Study start
December 10, 2025
Record last updated
August 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

TARA-001-301 is a Phase 2b/3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of Choline Chloride for Injection (Low Dose and High Dose) versus Placebo in adolescents (ages 12 to \< 18 years of age) and adults (≥ 18 years of age) with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Participants will be enrolled in one of 2 parts, each part will be followed by an open-label extension period of approximately a year.

Part 1: Open-Label Dose-Selection Phase Part 2: Double-Blind, Placebo-Controlled Phase

The purpose of the Open-Label Dose-Selection Phase is to evaluate the safety, tolerability, how Choline Chloride for Injection (study drug) is distributed in the body, and to select 2 of 3 doses for testing in the Double-Blind, Placebo-Controlled Phase.

The purpose of the Double-Blind, Placebo-Controlled Phase is to assess the safety of the study drug and how well the study drug works at the 2 selected dose levels.

Being studied: Choline Chloride for Injection; Placebo

Conditions: Choline Deficiency; Liver Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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

Key Exclusion Criteria

  • 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.

Recruiting US locations

  • University of Colorado School of Medicine

    Aurora, CO 80045

    Site contact: Use Central Contact

  • Floridian Clinical Research

    Miami Lakes, FL 33016

    Site contact: Use Central Contact

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, IL 60611

    Site contact: Use Central Contact

  • Duke Clinic - Abdominal Transplant Research Office

    Durham, NC 27710

    Site contact: Use Central Contact

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Use Central Contact

  • Pinnacle Clinical Research- San Antonio

    San Antonio, TX 78229

    Site contact: Use Central Contact

Study contacts (from the official record)

  • Chief Scientific Operations Officer · 16468440337 · clinicaltrials@protaratx.com
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Study of Choline Chloride for Injection in Adolescent and Adult… (NCT06910943) | Bored Studies