An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
Part of paid clinical trials in Modesto, California.
- Sponsor
- Neuvosyn Laboratories, LLC
- Study ID
- NCT07747103
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Hypothyroidism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Desiccated Porcine Thyroid Extract Tablets — DRUGNorth Star
Study Details
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.
Key Dates
- First listed
- Aug 5, 2026
- Start date
- Jun 30, 2026
- Status verified
- Jul 2026
- Primary completion
- Nov 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 466 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: North StarNorth Star Desiccated Porcine Thyroid Extract Tablets
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 ]
Locations (25)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Paradigm Clinical Research Centers, LLC | Modesto | California | 95355 | Site Coordinator 209-554-4844 |
| Paradigm Clinical Research Centers, LLC | Redding | California | 96001 | Site Coordinator 530-247-7049 |
| Paradigm Clinical Research Centers, LLC | San Diego | California | 92108 | Site Coordinator 858-274-4226 |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | Site Coordinator 925-298-5147 |
| Paradigm Clinical Research Centers, LLC | Aurora | Colorado | 80012 | Site Coordinator 303-219-1830 |
| Accel Research | Lakeland | Florida | 33803 | Site Coordinator 863-940-2087 |
| Accel Research | Largo | Florida | 33777 | Site Coordinator 727-346-8839 |
| Advanced Medical Research Institute, LLC | Miami | Florida | 33147 | Site Coordinator 786-558-7300 |
| AppleMed Research Group, LLC | Miami | Florida | 33126 | Site Coordinator 305-667-8434 |
| 3Sync LLC | Miami Lakes | Florida | 33014 | Site Coordinator 786-850-8553 |
| 3Sync Research | Palm Springs | Florida | 33461 | Site Coordinator 561-910-5792 |
| Precision Clinical Research | Sunrise | Florida | 33351 | Site Coordinator 954-915-9991 |
| Paradigm Clinical Research Centers, LLC | Boise | Idaho | 83709 | Site Coordinator 208-801-7438 |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | Site Coordinator 617-477-4868 |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | Site Coordinator 978-655-7155 |
| M3 Wake Research - Las Vegas Wellness Way | Las Vegas | Nevada | 89106 | Site Coordinator 702-893-8968 |
| M3 Wake Research | Raleigh | North Carolina | 27612 | Site Coordinator 919-781-2514 |
| Progressive Medicine of the Triad, LLC | Winston-Salem | North Carolina | 27103 | Site Coordinator 336-768-3456 |
| M3 Wake Research | Charleston | South Carolina | 29414 | Site Coordinator 843-258-1852 |
| Coastal Carolina Research Center, LLC | North Charleston | South Carolina | 29405 | Site Coordinator 843-856-3784 |
| M3 Wake Research | Chattanooga | Tennessee | 37421 | Site Coordinator 423-698-4584 |
| M3 Wake Research | Dallas | Texas | 75246 | Site Coordinator 469-297-3074 |
| Advanced Medical Trials, LLC | Georgetown | Texas | 78628 | Site Coordinator 512-868-0901 |
| Olympus Clinical Research | Sugar Land | Texas | 77478 | Site Coordinator 346-397-4457 |
| Charlotteville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | Site Coordinator 434-817-2442 |
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