Trial studying safety and effects for Hypothyroidism
Official title An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
ClinicalTrials.gov ID: NCT07747103
What this study is testing
What is Desiccated Porcine Thyroid Extract Tablets?
Desiccated Porcine Thyroid Extract Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hypothyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Diagnosed with primary hypothyroidism, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day...
- 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...
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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 people, be pregnant, nursing or planning to become pregnant during the study
The study team makes the final eligibility decision.
Where it's taking place
- 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 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
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.