Trial · NCT05682482
LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients with Autoimmune Hypothyroidism.
NCT05682482, Phase 3, Recruiting, M. Medici
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients with Autoimmune Hypothyroidism. Trials, record NCT05682482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05682482
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients with Autoimmune Hypothyroidism.
- NCT number
- NCT05682482
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 600 participants, estimated
- Lead sponsor
- M. Medici
- Conditions
- Autoimmune Hypothyroidism
- Interventions
- LT3 (liothyronine), Placebo
- First posted
- 2023-01-12
- Last updated
- 2025-02-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from baseline to 52 weeks in the ThyPRO tiredness subscale scores. | 52 weeks | Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the tiredness subscale ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit. |
| Primary | Effect sizes in genetic subgroups | 52 weeks | In case it is confirmed that LT4/LT3 combination therapy reduces tiredness compared to LT4 treatment alone, we will simultaneously investigate whether effect sizes are higher in patients with genetic variation in the type 2 deiodinase (DIO2-rs225014) and effect sizes are higher in patients with genetic variation in the monocarboxylate transporter 10 (MCT10-rs17606253), ensuring control of the study-wise type 1 error (of 5% two-sided) across these three main questions. |
| Secondary | Mean change from baseline to 52 weeks in the ThyPRO-39 composite scale* scores. | 52 weeks | The Composite scale is based on 22 items from the Tiredness, Cognition, Anxiety, Depressivity, Emotional Susceptibility, Impaired Social life, Impaired Daily Life and Overall QoL subscales of the Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with each subscale ranging from 0-100 (higher scores indicate a worse outcome). The ThyPRO questionnaire will be performed at every RCT visit. |
| Secondary | Change from baseline to 52 weeks in the ThyPRO tiredness subscale scores ≥ minimal important difference (=14.3). | 52 weeks | Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the tiredness subscale ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit. |
| Secondary | Mean change from baseline to 52 weeks in the ThyPRO tiredness subscale scores in participants with a baseline score > 57 (= population mean, unpublished results; personal communication with Dr T Watt, developer of the ThyPRO questionnaire). | 52 weeks | Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the tiredness subscale ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit. |
| Secondary | Mean change from baseline to 52 weeks in the ThyPRO tiredness subscale scores in participants with a normal-range TSH level at 52 weeks. | 52 weeks | Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the tiredness subscale ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit. |
| Secondary | Determinants of the effects of LT4/LT3 combination therapy on tiredness. | 52 weeks | Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the tiredness subscale ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit. |
| Secondary | The (determinants of the) effects of LT4/LT3 combination therapy compared to LT4 therapy alone on other thyroid related complaints and quality of life. | 52 weeks | Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the subscales ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit. |
| Secondary | Number of adverse events in the LT4/LT3 combination therapy compared to the LT4 monotherapy groups. | 52 weeks | AEs are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product / trial procedure. All following AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be recorded, for which we also refer to the SmPCs for LT4 and LT3: * Hyperthyroidism (endocrine disorders subgroup) * Hypothyroidism (endocrine disorders subgroup) * All cardiac disorders subgroups * Erythroderma, rash and urticaria (skin and subcutaneous disorders subgroups) All other AEs will be recorded from CTCAE v 5.0 grade 3 onwards (= severe or medically significant but not immediately life-threatening). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40130156 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05682482
GET https://conductscience.org/api/trials/v1/NCT05682482/registered