NCT07682896 Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
| NCT ID | NCT07682896 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yarrow Bioscience, Inc. |
| Condition | Graves' Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2026-06-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 232 participants in total. It began in 2026-06-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body. The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2. Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.
Eligibility Criteria
Inclusion Criteria: * Have a documented diagnosis of Graves' Disease confirmed by the presence of thyroid-stimulating hormone receptor antibodies (TRAbs) by medical history or screening laboratory assessment * Have a pre-existing diagnosis of TED or, conversely, no evidence of TED at the ophthalmological examination performed during screening * Additional inclusion criteria are defined in the protocol Exclusion Criteria: * Previously treated with radioactive iodine (RAI) therapy or underwent total thyroidectomy * Received any dose of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening * Current treatment with teprotumumab or exposure to teprotumumab within 15 weeks prior to screening * History of hyperthyroidism not caused by Graves' disease (eg. toxic adenoma, or toxic multinodular goiter) within 6 months before the screening visit * Pregnant or lactating women * Additional exclusion criteria are defined in the protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07682896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Graves' Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07682896 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07682896 currently recruiting?
Yes, NCT07682896 is actively recruiting participants. Contact the research team at VL@YarrowBioscience.com for enrollment information.
Where is the NCT07682896 trial being conducted?
This trial is being conducted at Gilbert, United States, Phoenix, United States, Tucson, United States, La Mesa, United States and 11 additional locations.
Who is sponsoring the NCT07682896 clinical trial?
NCT07682896 is sponsored by Yarrow Bioscience, Inc.. The trial plans to enroll 232 participants.