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RecruitingNCT06910943THRIVE-3Updated Aug 24, 2026

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

A Phase 2/3 interventional study of Choline Chloride for Injection and Placebo in Choline Deficiency and Liver Injury, sponsored by Protara Therapeutics. Recruiting at 18 sites in 6 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Protara Therapeutics · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Choline Deficiency
  • Liver Injury

Browse trials for

Keywords

  • Intestinal Failure
  • Parenteral Nutrition
  • Parenteral Support
  • Choline Chloride
  • choline deficiency
03

In context

Intestinal Failure

64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.

This study's planned enrollment of 129 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.

Browse Intestinal Failure studies →

Lead sponsor

Protara Therapeutics is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Male or female 12 years of age or older at the time of signing the
  • 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 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 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 (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer)
  • 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
129 participants (estimated)

Study arms

  • Experimental
    Open-Label, Dose-Selection: Dose 1

    Drug: Choline Chloride for Injection

  • Experimental
    Open-Label, Dose-Selection: Dose 2

    Drug: Choline Chloride for Injection

  • Experimental
    Open-Label, Dose-Selection: Dose 3

    Drug: Choline Chloride for Injection

  • Experimental
    Double-Blind, Placebo-Controlled: High Dose

    Drug: Choline Chloride for Injection

  • Experimental
    Double-Blind, Placebo-Controlled: Low Dose

    Drug: Choline Chloride for Injection

  • Placebo comparator
    Double-Blind, Placebo-Controlled: Placebo

    Drug: Placebo

  • Experimental
    Open Label Extension: High Dose

    Drug: Choline Chloride for Injection

  • Experimental
    Open Label Extension: Low Dose

    Drug: Choline Chloride for Injection

Interventions

06

What researchers measure

Primary outcomes

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

    Cmax = maximum concentration

    Time frame: Week 1 to Week 8

  2. Open-Label Dose-Selection Phase: Open-Label Dose-Selection Phase: PK of plasma free choline (Tmax) during Week 1 and Week 8 Visits

    Tmax = time of maximum concentration

    Time frame: Week 1 to Week 8

  3. Open-Label Dose-Selection Phase: PK of plasma free choline (AUC(0-TAU)) during Week 1 and Week 8 Visits

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

    Time frame: Week 1 to Week 8

  4. Open-Label Dose-Selection Phase: Change from Baseline in plasma free choline concentrations at Week 8

    Time frame: Week 1 to Week 8

  5. Open-Label Dose-Selection Phase and Double-Blind, Placebo-Controlled Phase, Open-Label Extension Phase: Incidence and severity of TEAEs Incidence of TESAEs

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

    Time frame: Week 1 to Week 64

  6. 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 Placebo

    Tmax = time of maximum concentration

    Time frame: Week 1 to Week 8

  7. 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 64

    Time frame: Week 64

  8. 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)

    Time frame: Week 8 to Week 64

  9. Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % with plasma free choline concentrations of ≥9.5 nmol/mL at Week 64

    Time frame: Week 1 to Week 64

  10. 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 Injection

    Time frame: Week 8 to Week 64

Secondary outcomes

  1. Open-Label Dose-Selection Phase: Change from Baseline to Week 8 in ALP, AST, ALT, GGT, VLDL, total bilirubin, direct bilirubin levels, CPK, homocysteine and albumin levels

    ALP = alkaline phosphatase, AST = aspartate aminotransferase, ALT = alanine transaminase, GGT = gamma-glutamyl transpeptidase, VLDL = very low-density lipoprotein, CPK = creatine phosphokinase

    Time frame: Week 1 to Week 8

  2. Open-Label Dose-Selection Phase: Triplicate QTc measurements collected during Week 1 and Week 8, and changes from pre-infusion QTc at Week 1 to all post-baseline timepoints

    QTc = QT corrected for heart rate

    Time frame: Week 1 to Week 8

  3. Open-Label Dose-Selection Phase: Percentage of participants achieving plasma free choline concentration Cmax ≥ 9.5 nmol/mL at Week 8

    Cmax = maximum concentration

    Time frame: Week 1 to Week 8

  4. Open-Label Dose-Selection Phase: Percentage of participants maintaining plasma free choline concentration Cmax ≥ 9.5 nmol/mL at Week 8

    Cmax = maximum concentration

    Time frame: Week 1 to Week 8

  5. Open-Label Dose-Selection Phase: Change from Baseline to Week 8 in height, weight and BMI

    BMI = body mass index Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Week 1 to Week 8

  6. Open-Label Dose-Selection Phase: Percentage of participants with no worsening of steatosis from Baseline to Week 8 as measured by MRI-PDFF

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 8

  7. Open-Label Dose-Selection Phase: Percentage of participants with any improvement of steatosis from Baseline to Week 8 as measured by MRI-PDFF

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 8

  8. Double-Blind, Placebo-Controlled Phase: Change from Baseline and Week 8 in peak plasma free choline concentrations (Cmax) at Week 24 in participants receiving Choline Chloride for Injection versus Placebo

    Tmax = time of maximum concentration

    Time frame: Week 1 to Week 24

  9. Double-Blind, Placebo-Controlled Phase: Percentage of participants achieving plasma free choline concentration Cmax ≥ 9.5 nmol/mL at Week 8

    Cmax = maximum concentration

    Time frame: Week 1 to Week 8

  10. Double-Blind, Placebo-Controlled Phase: Percentage of participants maintaining plasma free choline concentration Cmax ≥ 9.5 nmol/mL at Week 8 and Week 24 (ie, through Week 24)

    Cmax = maximum concentration

    Time frame: Week 1 to Week 24

  11. Double-Blind, Placebo-Controlled Phase: Change from Baseline to Week 8 and Week 24 in height, weight and BMI

    BMI = body mass index Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Week 1 to Week 24

  12. Double-Blind, Placebo-Controlled Phase: Change from Baseline to Week 8 and Week 24 in ALP, AST, ALT, GGT, VLDL, total bilirubin, direct bilirubin levels, CPK, homocysteine and albumin levels

    ALP = alkaline phosphatase, AST = aspartate aminotransferase, ALT = alanine transaminase, GGT = gamma-glutamyl transpeptidase, VLDL = very low-density lipoprotein, CPK = creatine phosphokinase

    Time frame: Week 1 to Week 24

  13. Double-Blind, Placebo-Controlled Phase: Percentage of participants with no worsening of steatosis from Baseline to Week 24 as measured by MRI-PDFF

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 24

  14. Double-Blind, Placebo-Controlled Phase: Percentage of participants with any improvement of steatosis from Baseline on MRI-PDFF at Week 24

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 24

  15. Double-Blind, Placebo-Controlled Phase: Percentage of participants with no worsening in fibrosis grade from Baseline to Week 24, as measured by MRE and ELF test

    MRE = magnetic resonance elastography, ELF = enhanced liver fibrosis

    Time frame: Week 1 to Week 24

  16. Double-Blind, Placebo-Controlled Phase: Percentage of participants with improvement in fibrosis grade from Baseline to Week 24, as measured by MRE and ELF test

    MRE = magnetic resonance elastography, ELF = enhanced liver fibrosis

    Time frame: Week 1 to Week 24

  17. Double-Blind, Placebo-Controlled Phase: Percentage of participants with improvement of steatosis from Baseline on MRI-PDFF with improvement of ALP from Baseline to Week 24

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction, ALP = alkaline phosphatase

    Time frame: Week 1 to Week 24

  18. Double-Blind, Placebo-Controlled Phase: Percentage of participants with improvement of steatosis from Baseline on MRI-PDFF with improvement of ALT or AST from Baseline to Week 24

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction, ALT = alanine transaminase, AST = aspartate aminotransferase

    Time frame: Week 1 to Week 24

  19. Double-Blind, Placebo-Controlled Phase: Assessment of Quality of Life based on CLDQ at Baseline and Week 24

    CLDQ = chronic liver disease questionnaire

    Time frame: Week 1 to Week 24

  20. Double-Blind, Placebo-Controlled Phase: Assessment of Quality of Life based on PGIS at Baseline and PGIC at Week 24

    PGIC = patient global impression of change

    Time frame: Week 1 to Week 24

  21. Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase: Change from Baseline (Week 1) to Week 64 in ALP, AST, ALT, GGT, VLDL, total bilirubin, direct bilirubin levels, CPK, homocysteine and albumin levels

    ALP = alkaline phosphatase, AST = aspartate aminotransferase, ALT = alanine transaminase, GGT = gamma-glutamyl transpeptidase, VLDL = very low-density lipoprotein, CPK = creatine phosphokinase

    Time frame: Week 1 to Week 64

  22. Open-Label Extension Phase: Double-Blind, Placebo-Controlled Phase: Change from W1 to W64 in Choline Chloride for Injection group, and change from W24 to W64 in Placebo group in ALP, AST, ALT, GGT, VLDL, TBIL, DBil levels, CPK, homocysteine and albumin

    ALP = alkaline phosphatase, AST = aspartate aminotransferase, ALT = alanine transaminase, GGT = gamma-glutamyl transpeptidase, VLDL = very low-density lipoprotein, CPK = creatine phosphokinase, TBIL = total bilirubin, DBil = direct bilirubin

    Time frame: Week 1 to Week 64

  23. Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase Change from Baseline (Week 1) to Week 64 in height, weight and BMI

    BMI = body mass index Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Week 1 to Week 64

  24. Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: Change from W1 to W64 for participants in Choline Chloride for Injection group, and change from W24 to W64 for participants in Placebo group in height, weight and BMI

    BMI = body mass index Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Week 1 to Week 64

  25. Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase: Percentage of participants with no worsening of steatosis as measured by MRI-PDFF from Baseline (Week 1) to Week 64

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 64

  26. Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase: Percentage of participants with improvement of steatosis as measured by MRI-PDFF from Baseline (Week 1) to Week 64

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 64

  27. Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % of participants with no worsening of steatosis measured by MRI-PDFF from W1 to W64 in Choline Chloride for Injection group, and from W24 to W64 in Placebo group

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 64

  28. Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % of participants with improvement of steatosis measured by MRI-PDFF from W1 to W64 in Choline Chloride for Injection group, and from W24 to W64 in Placebo group

    MRI-PDFF = magnetic resonance imaging-estimated proton density fat fraction

    Time frame: Week 1 to Week 64

  29. Open-Label Extension Phase: Double-Blind, Placebo-Controlled Phase: % of participants with no worsening in fibrosis grade measured by MRE and ELF test from W1 to W64 in Choline Chloride for Injection group, and from W24 to W64 in Placebo group

    MRE = magnetic resonance elastography, ELF = enhanced liver fibrosis

    Time frame: Week 1 to Week 64

  30. Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % of participants with improvement in fibrosis measured by MRE and ELF test from W1 to W64 in Choline Chloride for Injection group, and W24 to W64 in Placebo group

    MRE = magnetic resonance elastography, ELF = enhanced liver fibrosis

    Time frame: Week 1 to Week 64

  31. Open-Label Extension Phase: Participants from Double-Blind Placebo-Controlled Phase: Assessment of QOL based on CLDQ at Week 64

    QOL = quality of life, CLDQ = chronic liver disease questionnaire

    Time frame: Week 64

  32. Open-Label Extension Phase: Participants from Double-Blind Placebo-Controlled Phase: Assessment of QOL based on PGIC at Week 64

    QOL = quality of life, PGIC = patient global impression of change

    Time frame: Week 64

07

Study locations

14 of 18 sites recruiting
  • University of Colorado School of Medicine
    Aurora, Colorado 80045, United States
    Recruiting
    • Use Central Contact · Contact
  • Floridian Clinical Research
    Miami Lakes, Florida 33016, United States
    Recruiting
    • Use Central Contact · Contact
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
    Recruiting
    • Use Central Contact · Contact
  • Nebraska Medicine
    Omaha, Nebraska 68105, United States
    Not yet recruiting
    • Use Central Contact · Contact
  • Columbia University Medical Center/ New York Presbyterian Hospital
    New York, New York 10032, United States
    Not yet recruiting
    • Use Central Contact · Contact
  • Duke Clinic - Abdominal Transplant Research Office
    Durham, North Carolina 27710, United States
    Recruiting
    • Use Central Contact · Contact
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    Recruiting
    • Use Central Contact · Contact
  • Pinnacle Clinical Research- San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
    • Use Central Contact · Contact
  • University Hospitals Leuven, Campus Gasthuisberg
    Leuven, 3000, Belgium
    Recruiting
    • Use Central Contact · Contact
  • Aalborg University Hospital, Department of Medical Gastroenterology
    Aalborg, 9100, Denmark
    Recruiting
    • Use Central Contact · Contact
  • Rigshospitalet - University Hospital Copenhagen
    Copenhagen, 2100, Denmark
    Recruiting
    • Use Central Contact · Contact
  • Beaujon Hospital - APHP
    Clichy, 92110, France
    Recruiting
    • Use Central Contact · Contact
  • Rennes University Hospital Center - Pontchaillou Site
    Rennes, 35000, France
    Withdrawn

    Not enrolling at this site.

  • CHRU Nancy - Barbois Hospital
    Vandœuvre-lès-Nancy, 54511, France
    Not yet recruiting
    • Use Central Contact · Contact
  • Charite - University Hospital Berlin
    Berlin, 13353, Germany
    Recruiting
    • Use Central Contact · Contact
  • University Duisburg-Essen, University Hospital Essen
    Essen, 45147, Germany
    Recruiting
    • Use Central Contact · Contact
  • M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center
    Lodz, 90-532, Poland
    Recruiting
    • Use Central Contact · Contact
  • Czerniakowski Hospital Sp. z o.o. (LCC)
    Warsaw, 00-739, Poland
    Recruiting
    • Use Central Contact · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Mar 2028, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2025
First posted
Apr 4, 2025
StartActual
Dec 10, 2025
Primary completionEst.
Mar 2028
CompletionEst.
Jan 2029
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06910943
Lead sponsor
Protara Therapeutics
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Dec 10, 2025
Primary completion
Mar 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Aug 24, 2026

Study contacts

Chief Scientific Operations Officer
Contact
clinicaltrials@protaratx.com
16468440337
Chief Scientific Operations Officer
study director · Protara Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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