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Levothyroxine Sodium

Clinical trials investigating Levothyroxine Sodium are studying how it works in different patient groups, including people with obesity, acute unilateral vestibulopathy, and thyroid-related metabolic disease. These trials look at outcomes such as weight loss, body composition, and quality of life, as well as safety and response in specific study settings.

Table of Contents

Trial overview

The source data includes three authorised interventional trials connected to Levothyroxine Sodium or related trial records, with study phases of Phase 2 and Phase 3.[1][2][3]

These studies focus on different patient groups, including people with obesity and thyroid-related findings, patients with acute unilateral vestibulopathy, and a separate Waldenstrom Macroglobulinemia study record in the source data.[1][2][3]

Study in obesity and thyroid-related features

The Phase 3 study with trial ID 2024-514377-22-00 is testing Levothyroxine Sodium in people with obesity and either subclinical hypothyroidism or normal thyroid function with TSH in the upper tertile of the normal range.[2]

Subclinical hypothyroidism means the thyroid may be underactive, but the signs are mild or only seen in blood tests.[2]

This study compares Levothyroxine Sodium plus a hypocaloric diet and physical exercise advice with placebo plus the same lifestyle plan.[2]

The main goal is to see whether the treatment helps with weight loss and body composition after 3 months.[2]

Body composition means how much of the body is fat, lean tissue, and water, not just total weight.[2]

The trial plans to enroll 286 subjects and is currently authorised.[2]

Study in acute unilateral vestibulopathy

The Phase 2 study with trial ID 2024-519515-34-00 is a monocentric, double-blind, placebo-controlled trial called T4U.[3]

Monocentric means it is run at one study center, and double-blind means neither the patient nor the study team knows who gets the active treatment or the placebo during the study.[3]

This trial includes patients with acute unilateral vestibulopathy (AUVP), a condition that affects balance and can cause sudden dizziness.[3]

The primary outcome is the change in the Dizziness Handicap Inventory (DHI) score from study entry to day 14.[3]

DHI is a questionnaire that measures how dizziness affects daily life and quality of life.[3]

The trial plans to enroll 48 participants and is authorised.[3]

Other trial data in the source set

The source data also includes trial NCT02952508, which is a Phase 2 study in Waldenstrom Macroglobulinemia with 65 planned participants.[1]

Its brief summary says the main objective is to determine the major response rate after CLR 131 in patients who have already received at least two prior lines of therapy.[1]

This record lists interventions that do not include Levothyroxine Sodium, so it should be viewed as separate background trial data in the source set rather than a Levothyroxine Sodium study.[1]

Outcomes and measures

The obesity study measures weight loss in both percentage and kilograms, along with BMI, waist and hip circumference, fat mass, fat-free mass, and body water by impedance measurement.[2]

Impedance measurement is a method that estimates body water and body composition by sending a small electrical signal through the body.[2]

The vestibulopathy study measures change in DHI over 14 days, which helps show whether the treatment changes how much dizziness disrupts daily life.[3]

The Waldenstrom Macroglobulinemia record measures major response rate, which includes complete response, very good partial response, or partial response.[1]

Key terms for patients

  • Placebo: a look-alike treatment with no active study drug, used for comparison in research.[2][3]
  • TSH: thyroid-stimulating hormone, a blood marker used to assess thyroid function.[2]
  • Physical exercise recommendations: advice to stay active as part of the study plan.[2]
  • Partial response: a meaningful improvement, but not a full disappearance of the disease being measured.[1]
  • Quality of life: how a health problem affects daily activities, comfort, and well-being.[3]
Trial ID Phase Condition studied Status Enrollment
2024-514377-22-00 Phase 3 Metabolic disease; obesity with subclinical hypothyroidism or high-normal TSH Authorised 286
2024-519515-34-00 Phase 2 Acute unilateral vestibulopathy (AUVP) Authorised 48
NCT02952508 Phase 2 Waldenstrom Macroglobulinemia Authorised 65

FAQ

  • What are clinical trials of Levothyroxine Sodium trying to find out? These trials are checking whether Levothyroxine Sodium helps with study-specific outcomes such as weight loss, body composition, or quality of life. Some trials also measure how well patients respond to treatment over time.
  • Who can take part in these trials? The target groups include adults with obesity and either subclinical hypothyroidism or normal thyroid function with high-normal TSH, and patients with acute unilateral vestibulopathy. Another study focuses on people with Waldenstrom Macroglobulinemia, but that trial does not study Levothyroxine Sodium.
  • What trial phases are listed for Levothyroxine Sodium studies? The Levothyroxine Sodium trials listed are Phase 2 and Phase 3 studies. This means they are testing the treatment in patient groups to measure effects and outcomes in more detail.
  • What conditions are being studied? The trials listed study obesity with thyroid-related features, acute unilateral vestibulopathy, and metabolic disease. Each trial has its own main goal and patient group.
  • How are the results measured in these trials? The studies measure outcomes such as weight loss, body mass index, waist and hip size, body fat, body water, and dizziness-related quality of life. One trial measures change in the Dizziness Handicap Inventory, which is a questionnaire about how dizziness affects daily life.

Ongoing Clinical Trials on Levothyroxine Sodium

  • Study on Levothyroxine and Low-Calorie Diet for Weight Loss in Obese Patients with Subclinical Hypothyroidism or High-Normal TSH Levels

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • A study to evaluate the use of levothyroxine sodium in patients with sudden onset of dizziness caused by inner ear issues.

    Not yet recruiting

    1 1
    Investigated drugs:
    Germany

  • Study of CLR 131 for Patients with Relapsed or Refractory Waldenstrom Macroglobulinemia

    Not recruiting

    1 1 1
    Investigated drugs:
    France Greece Spain

Glossary

  • Clinical trial: A research study in people that tests a treatment, procedure, or strategy to see how well it works and how safe it is.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Phase 2: A trial stage that looks at whether a treatment shows signs of working and continues to collect safety information.
  • Phase 3: A later trial stage that compares treatments in larger groups and measures how well they work.
  • Enrollment: The number of people planned to join a study.
  • Primary outcome: The main result the researchers want to measure to answer the study question.
  • Major response rate (MRR): The proportion of patients who reach a major level of improvement, such as complete response, very good partial response, or partial response.
  • Complete response (CR): A study result meaning the disease or problem is no longer found by the study criteria.
  • Very good partial response (VGPR): A strong improvement, but not a full disappearance of the disease or problem.
  • Partial response (PR): An improvement that is smaller than a very good partial response, but still meaningful.
  • Body mass index (BMI): A number based on height and weight that helps estimate body size.
  • Dizziness Handicap Inventory (DHI): A questionnaire that shows how much dizziness affects a person’s daily life.

References

  1. https://clinicaltrials.eu/trial/study-of-clr-131-for-patients-with-relapsed-or-refractory-waldenstrom-macroglobulinemia/
  2. https://clinicaltrials.gov/study/2024-514377-22-00
  3. https://clinicaltrials.gov/study/2024-519515-34-00