NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07747103

RecruitingPhase 3

Sponsor: Neuvosyn Laboratories, LLC

Conditions: Hypothyroidism

Interventions: Desiccated Porcine Thyroid Extract Tablets

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (25)

Modesto, California, United States
Redding, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Aurora, Colorado, United States
Lakeland, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Palm Springs, Florida, United States
Sunrise, Florida, United States
Boise, Idaho, United States
Boston, Massachusetts, United States
Methuen, Massachusetts, United States
Las Vegas, Nevada, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Charleston, South Carolina, United States
North Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Georgetown, Texas, United States
Sugar Land, Texas, United States
Charlottesville, Virginia, United States