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Recruiting NCT07747103

An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.

Phase III Interventional Hypothyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Desiccated Porcine Thyroid Extract Tablets.
Who it may be relevant to
Registry conditions: Hypothyroidism. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism

Overview

The North Star study is a multi-center, Phase 3, open-label, single-arm clinical study to evaluate the Efficacy and Safety of North Star therapy.

Detailed description

An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism

Interventions

  • Drug Desiccated Porcine Thyroid Extract Tablets
    North Star

Primary outcome measures

  • Thyroid-stimulating hormone (TSH) levels within the normal reference range at 24 weeks and at a prior post-baseline visit with no intervening out of range values [Time frame: 24 weeks]
Secondary outcome measures (1)
  • Collection and review of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions, adverse events of special interest, clinical laboratory evaluations, 12-lead ECG, and physical examination. [Time frame: 30 weeks]

Eligibility criteria

Inclusion criteria

  • Diagnosed with primary hypothyroidism, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening
  • Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT4.
  • Agree to practice a method of contraception
  • Female patients not pregnant or lactating at Screening
  • Agree to practice a method of contraception of greater than 90% reliability
  • Willing to give written informed consent for the Study
  • Provide written authorization for use and disclosure of protected health information

Exclusion criteria

  • Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star
  • Hospitalization for a major illness within 5 weeks prior to Screening
  • Concomitant use of prohibited medications or supplements
  • Have uncontrolled diabetes
  • Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening
  • Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.
  • For female subjects, be pregnant, nursing or planning to become pregnant during the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 25 centers
  • Paradigm Clinical Research Centers, LLC — Modesto
  • Paradigm Clinical Research Centers, LLC — Redding
  • Paradigm Clinical Research Centers, LLC — San Diego
  • Sunwise Clinical Research — Walnut Creek
  • Paradigm Clinical Research Centers, LLC — Aurora
  • Accel Research — Lakeland
  • Accel Research — Largo
  • AppleMed Research Group, LLC — Miami
  • … and 17 more centers

Identifiers

NCT: NCT07747103 · NorthStar003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗