A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

NCT ID: NCT05412979

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-29

Study Completion Date

2023-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary hypothyroidism.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ST-1891

Group Type EXPERIMENTAL

ST-1891

Intervention Type DRUG

ST-1891

Levothyroxine

Group Type ACTIVE_COMPARATOR

Levothyroxine

Intervention Type DRUG

Levothyroxine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ST-1891

ST-1891

Intervention Type DRUG

Levothyroxine

Levothyroxine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with primary hypothyroidism
* On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening
* On a stable daily dose of levothyroxine for the 3 months prior to Screening
* Willing to give written informed consent for the Study

Exclusion Criteria

* Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of ST-1891 or levothyroxine
* Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening
* Anticipated initiation or change in concomitant medications
* Concomitant use of prohibited medications
* Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sention Therapeutics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sention Investigational Site

Greenbrae, California, United States

Site Status

Sention Investigational Site

Newhall, California, United States

Site Status

Sention Investigational Site

Denver, Colorado, United States

Site Status

Sention Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Sention Investigational Site

Jacksonville, Florida, United States

Site Status

Sention Investigational Site

New Port Richey, Florida, United States

Site Status

Sention Investigational Site

Palm Harbor, Florida, United States

Site Status

Sention Investigational Site

Atlanta, Georgia, United States

Site Status

Sention Investigational Site

Lawrenceville, Georgia, United States

Site Status

Sention Investigational Site

Roswell, Georgia, United States

Site Status

Sention Investigational Site

Evergreen Park, Illinois, United States

Site Status

Sention Investigational Site

Newburgh, Indiana, United States

Site Status

Sention Investigational Site

South Bend, Indiana, United States

Site Status

Sention Investigational Site

Ankeny, Iowa, United States

Site Status

Sention Investigational Site

Louisville, Kentucky, United States

Site Status

Sention Investigational Site

Dearborn, Michigan, United States

Site Status

Sention Investigational Site

Chesterfield, Missouri, United States

Site Status

Sention Investigational Site

Jefferson City, Missouri, United States

Site Status

Sention Investigational Site

Staten Island, New York, United States

Site Status

Sention Investigational Site

Cary, North Carolina, United States

Site Status

Sention Investigational Site

Greenville, North Carolina, United States

Site Status

Sention Investigational Site

Hickory, North Carolina, United States

Site Status

Sention Investigational Site

Morehead City, North Carolina, United States

Site Status

Sention Investigational Site

Raleigh, North Carolina, United States

Site Status

Sention Investigational Site

Rocky Mount, North Carolina, United States

Site Status

Sention Investigational Site

Salisbury, North Carolina, United States

Site Status

Sention Investigational Site

Wilmington, North Carolina, United States

Site Status

Sention Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

Sention Investigational Site

Bristol, Tennessee, United States

Site Status

Sention Investigational Site

Chattanooga, Tennessee, United States

Site Status

Sention Investigational Site

Memphis, Tennessee, United States

Site Status

Sention Investigational Site

Austin, Texas, United States

Site Status

Sention Investigational Site

Austin, Texas, United States

Site Status

Sention Investigational Site

Benbrook, Texas, United States

Site Status

Sention Investigational Site

Live Oak, Texas, United States

Site Status

Sention Investigational Site

Round Rock, Texas, United States

Site Status

Sention Investigational Site

Webster, Texas, United States

Site Status

Sention Investigational Site

Virginia Beach, Virginia, United States

Site Status

Sention Investigational Site

Renton, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ST-1891-201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Novel Approaches to the Treatment of Hypothyroidism
NCT06731764 RECRUITING PHASE2/PHASE3