T4/T3 Therapy in Hypothyroidism
NCT07424183 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-21
Summary
This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.
Conditions
- Hypothyroidism Primary
Interventions
- DRUG
-
Liothyronine (L-T3)
Participants will either take LT3 with an LT4 dose that is reduced from baseline or they will take liothyronine placebo with their baseline LT4 dose.
- DRUG
-
Levothyroxine Sodium (LT4) Tablets
All participants will take levothyroxine.
- DRUG
-
Liothyronine (LT3) placebo
Identical placebo tablet without containing liothyronine
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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