Hypothyroidism study: Levothyroxine
Official title Novel Approaches to the Treatment of Hypothyroidism
ClinicalTrials.gov ID: NCT06731764
What this study is testing
What is Levothyroxine?
This is an investigational treatment being studied for hypothyroidism. It is designed to replace the thyroid hormone that the body is not making enough of.
Also referred to as LT4.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find a safe and effective way to treat low thyroid function that might improve health and quality of life better than current standard care.
- Who it's for
- The study is looking for adults who have hypothyroidism (low thyroid hormone levels).
- What's involved
- Participants will be randomly assigned to receive either a combination of two thyroid hormones or a single hormone, all in pill form, while keeping their identity and treatment details hidden from both them and the doctors.
- Time commitment
- The study involves a pilot phase with escalating doses to prepare for larger future trials, but the specific duration and visit schedule are not detailed in the provided text.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg
You likely can't join if
- Body weight \ 100 Kg.
- Indication for TSH suppression (high risk follicular-derived thyroid cancer).
- Secondary (pituitary) hypothyroidism (ICD-10 E23.0); Pregnancy; breastfeeding; uncontrolled diabetes (HbA1c \>8.5% at screening)
- Patients receiving lipid-lowering therapies must maintain the same dose throughout the participation in the study.
- Patients receiving anti-acid (H2 blockers, proton pump inhibitors) therapies must maintain the same dose throughout the participation in the study.
- Bariatric surgery, initiation of GLP-1 agonist therapy (irrespective of the indication), enrollment in structured weight loss programs will result in...
See the full eligibility criteria
- History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg
- Body weight \ 100 Kg.
- Indication for TSH suppression (high risk follicular-derived thyroid cancer).
- Secondary (pituitary) hypothyroidism (ICD-10 E23.0); Pregnancy; breastfeeding; uncontrolled diabetes (HbA1c \>8.5% at screening); use of oral Semaglutide (Rybelsus)
- Patients receiving lipid-lowering therapies must maintain the same dose throughout the participation in the study. Changes in lipid lowering therapy/dose will result in termination from the study.
- Patients receiving anti-acid (H2 blockers, proton pump inhibitors) therapies must maintain the same dose throughout the participation in the study.
- Bariatric surgery, initiation of GLP-1 agonist therapy (irrespective of the indication), enrollment in structured weight loss programs will result in dismissal from the study.
- Current pregnancy, pregnancy planned within the next 6 months, and lack of contraception in women of reproductive age will be exclusionary.
The study team makes the final eligibility decision.
Where it is enrolling
- Farmington, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Farmington, Connecticut, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.