Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Graves' Disease
In brief
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.
Key facts
- Study ID
- NCT07682896
- Run by
- Yarrow Bioscience, Inc.
- People needed
- 232
- Starts
- 2026-06-10
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Site 117 — Conroe, Texas, United States (enrolling)
- Site 118 — Macon, Georgia, United States (enrolling)
- Site 107 — Livonia, Michigan, United States (enrolling)
- Site 106 — Fort Worth, Texas, United States (enrolling)
- Site 110 — Houston, Texas, United States (enrolling)
- Site 101 — Humble, Texas, United States (enrolling)
- Site 116 — San Antonio, Texas, United States (enrolling)
- Site 109 — Miami Lakes, Florida, United States (enrolling)
- Site 100 — Amarillo, Texas, United States (enrolling)
- Site 112 — Gilbert, Arizona, United States (enrolling)
- Site 108 — Omaha, Nebraska, United States
- Site 129 — Niagara Falls, New York, United States
- Site 120 — Orchard Park, New York, United States
- Site 124 — Sayre, Pennsylvania, United States
- Site 128 — Edinburg, Texas, United States
- Site 127 — El Paso, Texas, United States
- Site 119 — Chesapeake, Virginia, United States
- Site 151 — East Melbourne, Victoria, Australia
- Site 150 — Melbourne N., Victoria, Australia
- Site 130 — Phoenix, Arizona, United States
- Site 121 — La Mesa, California, United States
- Site 103 — Sacramento, California, United States
- Site 111 — San Francisco, California, United States
- Site 105 — Torrance, California, United States
- Site 115 — Palm Harbor, Florida, United States
Full record on ClinicalTrials.gov
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