Monocarboxylate Transporter 8 DeficiencyPhase 3ReTRIACtNCT05579327
Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)
A Phase 3 study testing Tiratricol in people with Monocarboxylate Transporter 8 Deficiency and Allan-Herndon-Dudley Syndrome, run by Rare Thyroid Therapeutics International AB at 8 sites in 3 countries.
Trial summary
This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency. Male participants, from 4 years of age (at randomization) and having demonstrated stable maintenance treatment with tiratricol, will be randomized to receive… Read more about this study
- Who is it for?
- Ages 4 years and older, men only
- Conditions the study is for
- Monocarboxylate Transporter 8 Deficiency, Allan-Herndon-Dudley Syndrome
- What is being tested?
- Tiratricol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 21 Jul 2023to 3 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male participants diagnosed with a pathogenic mutation in the MCT8 gene, confirmed with a genetic test.
- Serum total T3 concentration above the ULN of the age specific normal range:
- at the time of diagnosis (or the closest sample taken prior to first ever treatment with tiratricol) for participants who are currently treated with tiratricol (if serum total T3 concentration is not available, free T3 results from standard of care samples may be used)
- in the Screening Visit sample:
- For participants who have never received and/or are currently not receiving tiratricol.
- For participants who stopped prohibited medications per exclusion criterion #6.
- Participants will be aged 4 years or older at the time of randomization. Participants entering screening who are <4 years of age but expected to be aged 4 years at randomization should be discussed with the medical monitor.
- Signed and dated informed consent form from the parents or legal guardian.
Who cannot join
- Major illness or recent major surgery unrelated to MCT8 deficiency (in the principal investigator's judgement), defined as:
- Conditions requiring repeated hospitalizations that are likely to confound ability to participate in the trial.
- Major illness in the 3 months prior to the Screening Visit that is likely to confound the ability of the participant to participate fully within the trial and/or confound the assessment of serum total T3 and/or safety.
- Major surgery within the 3 months prior to the Screening Visit or planned to take place during the study, including but not limited to major abdominal/thoracic/neurosurgical procedures.
- Major/minor abdominal and/or maxillofacial surgery that may inhibit the administration and/or absorption of study drug.
- Body weight <10 kg at the Screening Visit.
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- Patients who are participating, or intend to participate, in other therapeutic and/or interventional clinical studies during the study period.
- History of allergic reactions to components of tiratricol or any excipients in the investigational product (IP).
- Participants with any contra-indication for treatment with tiratricol or any excipients in the IP.
- Participants who have used other T3 analogues, levothyroxine, propylthiouracil, or other antithyroid medications within 6 weeks of screening.
- Randomization Criteria:
- In addition to the eligibility criteria, participants must meet further criteria at the time of randomization to enter the Randomized Treatment Period.
- Confirmation that the "Stable Dose Criterion" has been met.
- Absence of any new or exacerbated medical or surgical condition that fulfils Exclusion criterion #1.
- Confirmation that participant is at least 4 years of age at the time of randomization.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
Rare Disease Research, LLC
Atlanta, Georgia, 30329
Rare Disease Research, LLC
Hillsborough, North Carolina, 27278
Rare Disease Research, LLC
Kissimmee, Florida, 34746
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Tranquil Clinical and Research Consulting Services
Webster, Texas, 77598
About this study
Official title: Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency): A Double-blind, Randomized, Placebo-controlled Study
This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency. Male participants, from 4 years of age (at randomization) and having demonstrated stable maintenance treatment with tiratricol, will be randomized to receive placebo or tiratricol for 30 days or until reaching the rescue criterion (serum total triiodothyronine [T3] > upper limit of normal [ULN] of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). The research hypothesis to be tested is that, for participants in the placebo group, removal of tiratricol will lead to an increase of serum total T3 concentration, measured by liquid chromatography with tandem mass spectrometry (LC/MS/MS), above the ULN and requirement of rescue treatment with tiratricol, compared to those who continue to receive tiratricol.
Read the detailed description
The Screening Period includes a Screening Visit and a period of open-label treatment in which a stable maintenance dose of tiratricol, essential for progression into the Randomized Treatment Period, will be established. The duration of this period will vary depending on whether the participant is currently receiving treatment with tiratricol at the time of enrollment in the study (Cohort A), or if they are considered to be tiratricol treatment-naïve (Cohort B). Participants are considered to be tiratricol-naïve if they have never previously been administered tiratricol, or have previously received tiratricol but are not receiving tiratricol at the time of enrollment.
For participants in Cohort A, once eligibility is confirmed during the Screening Visit, the study starts with a Run-in Period to ensure that participants are being administered a stable dose of tiratricol, as determined by meeting the Stable Dose Criterion.
For participants in Cohort B, once eligibility is confirmed during the Screening Visit, the study starts with a Dose Titration Period to allow titration to a stable dose of tiratricol, as determined by meeting the Stable Dose Criterion.
The Stable Dose Criterion is defined as at least 4 weeks' treatment (during the period from the start of screening to randomization) at a fixed daily dose that is targeting a serum total T3, measured by LC/MS/MS, at the lower limit of normal (LLN) with at least 2 consecutive serum total T3 results that are within the study titration range: within 20% below the LLN to the 75th percentile of the normal range for serum total T3 (i.e., LLN + 0.75×[ULN-LLN]).
An evaluable participant is defined as a participant who completes the Randomized Treatment Period either by completing 30 days of double-blind treatment without meeting the rescue criterion or by meeting the rescue criterion.
- Being tested
- Tiratricol, Placebo
- Keywords
- MCT8, MCT8 deficiency, Allan-Herndon-Dudley syndrome, Tiratricol, Triac
- Medical subject headings
- Allan-Herndon-Dudley syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiratricolDrug
Tiratricol tablets are flat tablets that contain 350 µg tiratricol. Treatment will be administered orally or via percutaneous endoscopic gastrostomy (PEG) tube; tablets will be suspended in water and, if needed, mixed with mashed food for oral administration or administered in water through the PEG tube as applicable.
PlaceboDrug
Placebo tablets will be identical in appearance to tiratricol tablets but contain no tiratricol. Treatment will be administered orally or via PEG tube; tablets will be suspended in water and, if needed, mixed with mashed food for oral administration or administered in water through the PEG tube as applicable. During the Randomized Treatment Period, participants will receive the same number of tablets as the stable dose of open-label tiratricol they were receiving before randomization.
| Study group | Role | What they receive |
|---|---|---|
| Tiratricol | Experimental | Not described Receives: Drug: Tiratricol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change from baseline in serum total T3 (ln-transformed) during the 30-day double-blind Randomized Treatment Period
Measured: Baseline to Day 30
Proportion of participants who meet the rescue criterion (serum total T3 > ULN) during the 30-day double-blind Randomized Treatment Period
Measured: Baseline to Day 30
Secondary outcomes (11)
Change in serum thyroid hormone variables (T3, T4, TSH, fT3, and fT4)
Measured: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Heart rate
Measured: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Systolic blood pressure
Measured: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Rate pressure product (heart rate × systolic blood pressure)
Measured: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Heart rate Z scores
Measured: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Body weight
Measured: From i) Screening to End of Study (up to 26 weeks), ii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks).
Safety endpoints: Number of participants with treatment-emergent adverse events (TEAEs)
Measured: From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks).
Safety endpoints: Number of participants with TEAEs related to clinical laboratory tests
Safety laboratory variables (full blood count, serum renal and liver biomarkers, total and low-density lipoprotein [LDL] cholesterol, and electrolytes).
Measured: From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks).
Safety endpoints: Number of participants with TEAEs related to vital signs variables
Standard vital signs variables (heart rate, temperature, respiration rate, blood pressure, and body weight).
Measured: From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks).
Safety endpoints: 12-lead Electrocardiograms (ECGs): Number of clinically significant abnormal results (investigator interpretations)
Measured: At Screening, Day 1, and End of Study (up to 26 weeks).
Safety endpoints: Physical examinations: Number of clinically significant abnormal results
Body systems include cardiovascular system, general appearance, gastrointestinal system, head/eyes/ears/nose/throat, musculoskeletal system, and nervous system.
Measured: From i) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks), ii) Baseline to Follow-up (up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start21 Jul 2023
- Primary completion22 Jul 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monocarboxylate Transporter 8 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients having demonstrated stable maintenance treatment with tiratricol will be randomized to receive placebo or tiratricol for 30 days or until reaching rescue criterion (serum total T3 \> ULN of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). In other words, the patients will be randomized to complete withdrawal of tiratricol treatment (placebo) for 30 days or to continue with the stable tiratricol maintenance treatment for 30 days. If, during the 30 days, a rescue criterion (serum total T3 \> ULN of the participant's normal range) is reached, the randomized treatment will be stopped, and the patient will go back on unblinded tiratricol treatment. Serum total T3 concentrations measured during the Randomized Treatment Period that are below the LLN of the normal range will not lead to any modifications to the blinded study drug administration schedule of daily tiratricol dosing.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rare Thyroid Therapeutics International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Egetis Therapeutics AB (publ)
- Responsible party
- Sponsor
- Investigators
- Andrew J. Bauer, MD, Principal investigator, Children's Hospital of PhiladelphiaW. E. Visser, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579327
- Sponsor's protocol ID
- MCT8-2021-3
- Acronym
- ReTRIACt
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency): A Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05579327
- Acronym / sponsor ID
- ReTRIACt / MCT8-2021-3
- Keywords
- MCT8, MCT8 deficiency, Allan-Herndon-Dudley syndrome, Tiratricol, Triac
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rare Thyroid Therapeutics International ABIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research, Egetis Therapeutics AB (publ)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency. Male participants, from 4 years of age (at randomization) and having demonstrated stable maintenance treatment with tiratricol, will be randomized to receive placebo or tiratricol for 30 days or until reaching the rescue criterion (serum total triiodothyronine [T3] > upper limit of normal [ULN] of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). The research hypothesis to be tested is that, for participants in the placebo group, removal of tiratricol will lead to an increase of serum total T3 concentration, measured by liquid chromatography with tandem mass spectrometry (LC/MS/MS), above the ULN and requirement of rescue treatment with tiratricol, compared to those who continue to receive tiratricol.
Detailed description
The Screening Period includes a Screening Visit and a period of open-label treatment in which a stable maintenance dose of tiratricol, essential for progression into the Randomized Treatment Period, will be established. The duration of this period will vary depending on whether the participant is currently receiving treatment with tiratricol at the time of enrollment in the study (Cohort A), or if they are considered to be tiratricol treatment-naïve (Cohort B). Participants are considered to be tiratricol-naïve if they have never previously been administered tiratricol, or have previously received tiratricol but are not receiving tiratricol at the time of enrollment.
For participants in Cohort A, once eligibility is confirmed during the Screening Visit, the study starts with a Run-in Period to ensure that participants are being administered a stable dose of tiratricol, as determined by meeting the Stable Dose Criterion.
For participants in Cohort B, once eligibility is confirmed during the Screening Visit, the study starts with a Dose Titration Period to allow titration to a stable dose of tiratricol, as determined by meeting the Stable Dose Criterion.
The Stable Dose Criterion is defined as at least 4 weeks' treatment (during the period from the start of screening to randomization) at a fixed daily dose that is targeting a serum total T3, measured by LC/MS/MS, at the lower limit of normal (LLN) with at least 2 consecutive serum total T3 results that are within the study titration range: within 20% below the LLN to the 75th percentile of the normal range for serum total T3 (i.e., LLN + 0.75×[ULN-LLN]).
An evaluable participant is defined as a participant who completes the Randomized Treatment Period either by completing 30 days of double-blind treatment without meeting the rescue criterion or by meeting the rescue criterion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients having demonstrated stable maintenance treatment with tiratricol will be randomized to receive placebo or tiratricol for 30 days or until reaching rescue criterion (serum total T3 > ULN of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). In other words, the patients will be randomized to complete withdrawal of tiratricol treatment (placebo) for 30 days or to continue with the stable tiratricol maintenance treatment for 30 days. If, during the 30 days, a rescue criterion (serum total T3 > ULN of the participant's normal range) is reached, the randomized treatment will be stopped, and the patient will go back on unblinded tiratricol treatment. Serum total T3 concentrations measured during the Randomized Treatment Period that are below the LLN of the normal range will not lead to any modifications to the blinded study drug administration schedule of daily tiratricol dosing.
| Arm | Type | Receives |
|---|---|---|
| Tiratricol | Experimental | Drug: Tiratricol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male participants diagnosed with a pathogenic mutation in the MCT8 gene, confirmed with a genetic test.
- Serum total T3 concentration above the ULN of the age specific normal range:
- Participants will be aged 4 years or older at the time of randomization. Participants entering screening who are <4 years of age but expected to be aged 4 years at randomization should be discussed with the medical monitor.
- Signed and dated informed consent form from the parents or legal guardian.
Key exclusion criteria (15 listed)
- Major illness or recent major surgery unrelated to MCT8 deficiency (in the principal investigator's judgement), defined as:
- Body weight <10 kg at the Screening Visit.
- Patients who are participating, or intend to participate, in other therapeutic and/or interventional clinical studies during the study period.
- History of allergic reactions to components of tiratricol or any excipients in the investigational product (IP).
- Participants with any contra-indication for treatment with tiratricol or any excipients in the IP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiratricolTiratricol tablets are flat tablets that contain 350 µg tiratricol. Treatment will be administered orally or via percutaneous endoscopic gastrostomy (PEG) tube; tablets will be suspended in water and, if needed, mixed with mashed food for oral administration or administered in water through the PEG tube as applicable. | Drug | Tiratricol |
| PlaceboPlacebo tablets will be identical in appearance to tiratricol tablets but contain no tiratricol. Treatment will be administered orally or via PEG tube; tablets will be suspended in water and, if needed, mixed with mashed food for oral administration or administered in water through the PEG tube as applicable. During the Randomized Treatment Period, participants will receive the same number of tablets as the stable dose of open-label tiratricol they were receiving before randomization. | Drug | Placebo |
Primary outcome
Rate of change from baseline in serum total T3 (ln-transformed) during the 30-day double-blind Randomized Treatment Period
Time frame: Baseline to Day 30
Proportion of participants who meet the rescue criterion (serum total T3 > ULN) during the 30-day double-blind Randomized Treatment Period
Time frame: Baseline to Day 30
11 secondary outcomes
Change in serum thyroid hormone variables (T3, T4, TSH, fT3, and fT4)
Time frame: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Heart rate
Time frame: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Systolic blood pressure
Time frame: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Rate pressure product (heart rate × systolic blood pressure)
Time frame: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Heart rate Z scores
Time frame: From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks)
Change in clinical endpoints: Body weight
Time frame: From i) Screening to End of Study (up to 26 weeks), ii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks).
Safety endpoints: Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks).
Safety endpoints: Number of participants with TEAEs related to clinical laboratory tests
Time frame: From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks).
Safety endpoints: Number of participants with TEAEs related to vital signs variables
Time frame: From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks).
Safety endpoints: 12-lead Electrocardiograms (ECGs): Number of clinically significant abnormal results (investigator interpretations)
Time frame: At Screening, Day 1, and End of Study (up to 26 weeks).
Safety endpoints: Physical examinations: Number of clinically significant abnormal results
Time frame: From i) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks), ii) Baseline to Follow-up (up to 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J. Bauer, MD principal investigator
Children's Hospital of Philadelphia
W. E. Visser, MD principal investigator
Erasmus Medical Center
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiratricol in people with Monocarboxylate Transporter 8 Deficiency and Allan-Herndon-Dudley Syndrome, run by Rare Thyroid Therapeutics International AB at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change from baseline in serum total T3 (ln-transformed) during the 30-day double-blind Randomized Treatment Period (time frame: Baseline to Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.