In short
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.
Key points
- Clinical trials investigating Levothyroxine Sodium are looking at different patient groups and different goals. One Phase 3 study is in people with obesity and thyroid-related features, and it measures weight loss and body composition. Another Phase 2 study is in patients with acute unilateral vestibulopathy and measures dizziness-related quality of life. A third Phase 2 trial in Waldenstrom Macroglobulinemia appears in the source data, but it studies a different drug and not Levothyroxine Sodium. Overall, the trials focus on patient outcomes such as response, body changes, and daily functioning.
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.
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.
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.
Subclinical hypothyroidism means the thyroid may be underactive, but the signs are mild or only seen in blood tests.
This study compares Levothyroxine Sodium plus a hypocaloric diet and physical exercise advice with placebo plus the same lifestyle plan.
The main goal is to see whether the treatment helps with weight loss and body composition after 3 months.
Body composition means how much of the body is fat, lean tissue, and water, not just total weight.
The trial plans to enroll 286 subjects and is currently authorised.
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.
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.
This trial includes patients with acute unilateral vestibulopathy (AUVP), a condition that affects balance and can cause sudden dizziness.
The primary outcome is the change in the Dizziness Handicap Inventory (DHI) score from study entry to day 14.
DHI is a questionnaire that measures how dizziness affects daily life and quality of life.
The trial plans to enroll 48 participants and is authorised.
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.
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.
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.
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.
Impedance measurement is a method that estimates body water and body composition by sending a small electrical signal through the body.
The vestibulopathy study measures change in DHI over 14 days, which helps show whether the treatment changes how much dizziness disrupts daily life.
The Waldenstrom Macroglobulinemia record measures major response rate, which includes complete response, very good partial response, or partial response.
Key terms for patients
- Placebo: a look-alike treatment with no active study drug, used for comparison in research.
- TSH: thyroid-stimulating hormone, a blood marker used to assess thyroid function.
- Physical exercise recommendations: advice to stay active as part of the study plan.
- Partial response: a meaningful improvement, but not a full disappearance of the disease being measured.
- Quality of life: how a health problem affects daily activities, comfort, and well-being.