LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients With Autoimmune Hypothyroidism.
Status:
Recruiting
Trial end date:
2026-05-01
Target enrollment:
Participant gender:
Summary
Hypothyroidism is common, affecting 5% of the general population, for which levothyroxine
(LT4) monotherapy is the standard treatment. Despite normalized serum thyroid hormone levels,
10-15% of LT4 treated patients have various persistent complaints, the most important of
which is tiredness. This could be explained by the fact that physiological T4/T3 ratios
cannot be reached with LT4 monotherapy, as in a healthy individual T3 is not only derived
from T4/T3 conversion but is also directly produced by the thyroid itself. Studies have
reported contradicting results as to whether addition of liothyronine (LT4/LT3 combination
therapy) in patients with persistent tiredness on LT4 monotherapy is effective or not.
Studies have suggested higher effectiveness in patients carrying genetic variation in the
type 2 deiodinase (DIO2-rs225014) and monocarboxylate transporter 10 (MCT10-rs17606253)
genes.
Objective: To investigate whether addition of liothyronine (LT4/LT3 combination therapy) in
in patients with persistent tiredness on LT4 monotherapy is effective or not in relieving
tiredness.
Phase:
Phase 3
Details
Lead Sponsor:
M. Medici
Collaborators:
ACE Pharmaceuticals BV ZonMw: The Netherlands Organisation for Health Research and Development