Hormone Replacement Therapy for Hypothyroidism

No longer recruiting at 24 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neuvosyn Laboratories, LLC

Must be taking: Thyroid replacement

Disqualifiers: Major illness, Pregnancy, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of a new hormone replacement therapy called North Star for individuals with hypothyroidism, a condition where the thyroid produces insufficient hormones. Researchers will compare North Star to the commonly used treatment, Levothyroxine, to assess safety and effectiveness. The trial seeks participants who have maintained a steady Levothyroxine dose for at least three months. Those managing hypothyroidism with medication for some time may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not start or change any medications during the study. It also prohibits the use of certain medications or supplements, so you may need to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that North Star was safe in earlier studies. These studies suggest that people generally handle the treatment well. No major reports of adverse side effects have emerged, indicating that most patients did not experience serious problems while using North Star.

The current research focuses on ensuring that patients can safely switch from Levothyroxine, a common thyroid medication, to North Star. So far, the results are promising, indicating that North Star might be a safe option for people with hypothyroidism. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hypothyroidism?

Unlike the standard treatment for hypothyroidism, which typically involves levothyroxine—a synthetic form of the thyroid hormone—North Star is an experimental therapy that offers a novel approach. Researchers are excited about North Star because it might have a different mechanism of action or delivery method that could provide more consistent hormone levels or fewer side effects. This innovative approach could potentially offer a new option for patients who don't respond well to traditional treatments or who experience unwanted side effects.

What evidence suggests that North Star might be an effective treatment for hypothyroidism?

Research has shown that North Star therapy, a treatment under study in this trial, might effectively treat hypothyroidism. Early studies suggest that patients switching from Levothyroxine, the trial's active comparator, to North Star can maintain stable thyroid hormone levels. This stability is crucial for managing hypothyroidism symptoms, such as fatigue and weight gain. Although detailed results are not yet available, early data appears promising, indicating that North Star could be a safe alternative. It may offer a different option for those not fully satisfied with Levothyroxine. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with primary hypothyroidism who've been on a stable dose of Levothyroxine for at least 12 weeks. Participants must not be pregnant, agree to use reliable contraception, and cannot have conditions affecting drug absorption or excretion. They shouldn't have had major illness hospitalization recently or be taking certain other medications.

Inclusion Criteria

Agree to practice a method of contraception

I have been diagnosed with an underactive thyroid.

I have been on thyroid replacement therapy for at least 6 months.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant during the study.

I have not been hospitalized for a serious illness in the last 4 weeks.

I expect to start or change my current medications soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dose conversion from Levothyroxine to North Star therapy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levothyroxine
• North Star

Trial Overview

The study compares the safety and effectiveness of a new hormone therapy called North Star against the standard treatment, Levothyroxine, in people with underactive thyroid glands. It's a Phase 2 trial where patients are randomly assigned to one of the treatments without knowing which one they receive.

How Is the Trial Designed?

Group I: North Star Experimental Treatment 1 Intervention

Group II: Levothyroxine Active Control 1 Intervention

Who Is Running the Clinical Trial?

Neuvosyn Laboratories, LLC

Lead Sponsor

Trials

1

Recruited

300+

Published Research Related to This Trial

Only 56% of the 400 outpatients receiving levothyroxine therapy were monitored according to the minimum recommended guidelines, highlighting a significant gap in patient care.

Patients who received proper monitoring experienced fewer adverse drug events (ADEs) related to levothyroxine (1% vs. 6%), and minority status and non-English language were associated with higher rates of these ADEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the adequacy of outpatient monitoring of thyroid replacement therapy. Stelfox, HT., Ahmed, SB., Fiskio, J., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05712421

NCT05712421 | A Study Evaluation the Safety and Efficacy ...

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

2.

trial.medpath.com

trial.medpath.com/clinical-trial/9346c4403503dd82/nct05712421-randomized-double-blind-hormone-replacement-therapy-safety-efficacy

A Study Evaluation the Safety and Efficacy of Hormone ...

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5873391/

Current evidence for the treatment of hypothyroidism with ...

One study found that, on average, patients newly diagnosed with hypothyroidism (n = 76) reported experiencing 30.2% of symptoms from a panel of 17 traditional ...

4.

aihresearch.com

aihresearch.com/enroll/hypothyroidism/

Hypothyroidism Study

The Northstar research study is studying the change in medication from Levothyroxine to North Star DTE in people who are diagnosed with hypothyroidism.

5.

withpower.com

withpower.com/trial/phase-2-hypothyroidism-1-2023-16f3f

Hormone Replacement Therapy for Hypothyroidism

This trial is testing if patients can safely switch from Levothyroxine to North Star therapy while keeping their thyroid hormone levels stable.

6.

pharmatimes.com

pharmatimes.com/news/north-star-shows-promise-in-phase-2-thyroid-trial/

North Star shows promise in phase 2 thyroid trial

The trial also demonstrated a favourable safety profile. Conducted under the investigational name North Star, the study was led by Acella ...

7.

alorapharma.com

alorapharma.com/news/acella-pharmaceuticals-llc-acella-pharmaceuticals-phase-ii-success.html

Press Releases Acella Pharmaceuticals Phase II Success

The Phase II Trial also demonstrated a favorable safety profile. Acella Pharmaceuticals is the maker of NP Thyroid®, the #1 prescribed DTE^ in ...

8.

fdaaa.trialstracker.net

fdaaa.trialstracker.net/trial/NCT05712421/

An ongoing trial by Neuvosyn Laboratories, LLC

A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine ...