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

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.

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Key information

Conditions

Graves' Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 151, East Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

Time frame: Baseline, Day 169
Proportion of participants with normal free triiodothyronine (FT3), free thyroxine (FT4), and thyroid-stimulating hormone (TSH) who discontinued anti-thyroid drugs (ATDs), regardless of concomitant levothyroxine use

Time frame: Baseline, Day 169

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Lacasse, MD

CONTACT

[email protected]

469-278-6161

Sponsors and collaborators

Lead sponsor

Yarrow Bioscience, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2029
First posted: Jul 6, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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