T4/T3 Therapy in Hypothyroidism

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07424183
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hypothyroidism Primary

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Liothyronine (L-T3) — DRUG
    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.
  • Levothyroxine Sodium (LT4) Tablets — DRUG
    All participants will take levothyroxine.
  • Liothyronine (LT3) placebo — DRUG
    Identical placebo tablet without containing liothyronine

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LT4+LT3
    Levothyroxine plus liothyronine therapy
  • Active Comparator: LT4+placebo
    Levothyroxine plus liothyronine placebo

Primary Outcome Measure

ThyPRO Composite QOL Scale [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Medicine, Smilow Center for Translational Resarch,PhiladelphiaPennsylvania19104-

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Penn Medicine, Smilow Center for Translational Resarch· Philadelphia, PA