RECRUITING Phase 2 ClinicalTrials.gov

Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease

Sponsor: Yarrow Bioscience, Inc. • ClinicalTrials.gov ID: NCT07682896

Registry updated: 2026-10-05

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Description

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.

Interventions

Experimental: YB-101 (Drug)
YB-101 is administered over a 24 week period.
Placebo YB-101 (Drug)
Placebo will be administered over a 24 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

Conditions

Graves' Disease

Locations

Site 112 — Gilbert, Arizona, United States
Site 130 — Phoenix, Arizona, United States
Site 132 — Tucson, 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 109 — Miami Lakes, Florida, United States
Site 115 — Palm Harbor, Florida, United States
Site 123 — Sarasota, Florida, United States
Site 118 — Macon, Georgia, United States
Site 122 — Bowling Green, Kentucky, United States
Site 126 — Flint, Michigan, United States
Site 107 — Livonia, Michigan, United States
Site 108 — Omaha, Nebraska, United States
Site 129 — Niagara Falls, New York, United States
Site 120 — Orchard Park, New York, United States
Site 131 — Cary, North Carolina, United States
Site 124 — Sayre, Pennsylvania, United States
Site 100 — Amarillo, Texas, United States
Site 117 — Conroe, Texas, United States
Site 133 — Dallas, Texas, United States
Site 128 — Edinburg, Texas, United States
Site 127 — El Paso, Texas, United States
Site 106 — Fort Worth, Texas, United States
Site 110 — Houston, Texas, United States
Site 101 — Humble, Texas, United States
Site 151 — East Melbourne, Victoria, Australia
Site 150 — Melbourne N., Victoria, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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