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

A Randomized, Blinded, Placebo-Controlled, Two-Part, Phase 2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of YB-101 in Participants With Graves' Disease

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Experimental: YB-101 (drug)
• Placebo YB-101 (drug)

Sponsor: Yarrow Bioscience, Inc. · Participants: 232 · Started: Jun 10, 2026

Contact the study team

• Victoria Lacasse, MD · Phone: 469-278-6161

Official record on ClinicalTrials.gov — NCT07682896

Locations in the U.S.

Conditions

• Graves Disease
• Hyperthyroidism

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.