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466 Participants NeededMy employer runs this trial

Desiccated Porcine Thyroid for Hypothyroidism

Recruiting at 24 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Neuvosyn Laboratories, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people diagnosed with hypothyroidism who may benefit from thyroid hormone replacement. Participants should meet the study's health requirements and not have conditions or factors that would prevent safe participation.

Inclusion Criteria

I have primary hypothyroidism and have taken a stable LT4 dose for at least 12 weeks.
Willing to give written informed consent for the Study
I am not pregnant or breastfeeding.
See 4 more

Exclusion Criteria

Hospitalization for a major illness within 5 weeks prior to Screening
I do not have any condition or past surgery that affects how my body processes medicine.
I am not taking any medications or supplements that are not allowed in this study.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Desiccated Porcine Thyroid Extract Tablets

Trial Overview

The study tests desiccated porcine thyroid extract tablets as a treatment for hypothyroidism. All participants receive this medication, and there is no comparison group. The goal is to see how well it works and how safe it is.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: North StarExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neuvosyn Laboratories, LLC

Lead Sponsor

Trials
1
Recruited
300+

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