A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism

Sponsor

Neuvosyn Laboratories, LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05712421

Collaborator

(none)

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism	Drug: North Star Drug: Levothyroxine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Subjects With Primary Hypothyroidism Who Are Euthyroid on Levothyroxine Replacement Therapy

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: North Star	Drug: North Star North Star
Active Comparator: Levothyroxine	Drug: Levothyroxine Levothyroxine

Arm

Intervention/Treatment

Experimental: North Star

Drug: North Star

North Star

Active Comparator: Levothyroxine

Drug: Levothyroxine

Levothyroxine

Outcome Measures

Primary Outcome Measures

The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range. [Week 30]

Secondary Outcome Measures

Proportion of subjects who are euthyroid as determined by serum TSH level within the normal reference range at the end of the treatment period. [Week 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with primary hypothyroidism
On continuous thyroid replacement therapy for at least 6 months before Study Entry
On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening
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 or levothyroxine
Hospitalization for a major illness within 4 weeks prior to Screening
Anticipated initiation or change in concomitant medications
Concomitant use of prohibited medications or supplements
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuvosyn Investigational Site	Birmingham	Alabama	United States	35209
2	Neuvosyn Investigational Site	Canoga Park	California	United States	91304
3	Neuvosyn Investigational Site	Greenbrae	California	United States	94904
4	Neuvosyn Investigational Site	Toluca Lake	California	United States	91602
5	Neuvosyn Investigational Site	Boca Raton	Florida	United States	33434
6	Neuvosyn Investigational Site	Miami	Florida	United States	33144
7	Neuvosyn Investigational Site	Miami	Florida	United States	33145
8	Neuvosyn Investigational Site	Miami	Florida	United States	33155
9	Neuvosyn Investigational Site	Miami	Florida	United States	33174
10	Neuvosyn Investigational Site	Miami	Florida	United States	33179
11	Neuvosyn Investigational Site	Sunrise	Florida	United States	33351
12	Neuvosyn Investigational Site	Acworth	Georgia	United States	30101
13	Neuvosyn Investigational Site	Atlanta	Georgia	United States	30318
14	Neuvosyn Investigational Site	Columbus	Georgia	United States	31904
15	Neuvosyn Investigational Site	Sugar Hill	Georgia	United States	30024
16	Neuvosyn Investigational Site	Saginaw	Michigan	United States	48602
17	Neuvosyn Investigational Site	Gladstone	Missouri	United States	64118
18	Neuvosyn Investigational Site	Williamsville	New York	United States	14221
19	Neuvosyn Investigational Site	Denver	North Carolina	United States	28037
20	Neuvosyn Investigational Site	Winston-Salem	North Carolina	United States	27103
21	Neuvosyn Investigational Site	Beavercreek	Ohio	United States	45440
22	Neuvosyn Investigational Site	Columbus	Ohio	United States	31904
23	Neuvosyn Investigational Site	Georgetown	Texas	United States	78628
24	Neuvosyn Investigational Site	Houston	Texas	United States	77040
25	Neuvosyn Investigational Site	Katy	Texas	United States	77450
26	Neuvosyn Investigational Site	Katy	Texas	United States	77494
27	Neuvosyn Investigational Site	Lewisville	Texas	United States	75067
28	Neuvosyn Investigational Site	Paris	Texas	United States	75462
29	Neuvosyn Investigational Site	Pearland	Texas	United States	77584
30	Neuvosyn Investigational Site	Stafford	Texas	United States	77477

Sponsors and Collaborators

Neuvosyn Laboratories, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neuvosyn Laboratories, LLC

ClinicalTrials.gov Identifier:

NCT05712421

Other Study ID Numbers:

NorthStar-02-001

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 3, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypothyroidism

Study Results

No Results Posted as of Feb 3, 2023