Hypothyroidism
Conditions
Brief summary
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
DRUGDesiccated Porcine Thyroid Extract Tablets
North Star
Sponsors
Neuvosyn Laboratories, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 weeks | Safety will be evaluated by tracking the frequency, severity, and relationship of adverse events to the study drug from the first dose through the end of the follow-up period. The number and percentage of participants experiencing any treatment-emergent adverse event (TEAE) will be summarized by system organ class and preferred term. In addition, SAEs and TEAEs leading to withdrawal from the study will be summarized. Observed values and change from Baseline values in vital signs (body temperature, systolic and diastolic blood pressure, pulse, and respiratory rate), ECG parameters for QT interval evaluation, clinical laboratory parameters (hematology, serum chemistry, urinalysis) and physical examinations (to include general al appearance, head, eyes, ears, nose, throat, neck, cardiovascular, lungs, abdominal, extremities, neurologic, skin, lymph nodes, and musculoskeletal system) will be summarized by time point. All safety analyses will be based on the safety population. |
Countries
United States
Outcome results
None listed