Recruiting
Phase 3

North Star Therapy

Sponsor:

Neuvosyn Laboratories, LLC

Code:

NCT07747103

Conditions

Hypothyroidism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Desiccated Porcine Thyroid Extract Tablets

Study Details

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.

Conditions

Hypothyroidism

Study ID

NCT07747103

Start date

Jun 30, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

466 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: North Star

North Star Desiccated Porcine Thyroid Extract Tablets

Interventions

Desiccated Porcine Thyroid Extract Tablets

North Star

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

AppleMed Research Group, LLC

Recruiting

Miami, Florida, United States, 33126

Contacts

Site Coordinator

305-667-8434

Advanced Medical Research Institute, LLC

Recruiting

Miami, Florida, United States, 33147

Contacts

Site Coordinator

786-558-7300

More Information

Sponsor

Neuvosyn Laboratories, LLC

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neuvosyn Laboratories, LLC on 2026-08-05.