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

June 30, 2026 updated by: Yarrow Bioscience, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

232

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Not yet recruiting
        • Site 151
      • Melbourne N., Victoria, Australia, 3051
        • Not yet recruiting
        • Site 150
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Not yet recruiting
        • Site 112
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Site 130
    • California
      • La Mesa, California, United States, 91942
        • Not yet recruiting
        • Site 121
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Site 125
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • Site 103
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • Site 111
      • Torrance, California, United States, 90502
        • Not yet recruiting
        • Site 105
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Not yet recruiting
        • Site 109
      • Palm Harbor, Florida, United States, 34684
        • Not yet recruiting
        • Site 115
      • Sarasota, Florida, United States, 34239
        • Not yet recruiting
        • Site 123
    • Georgia
      • Macon, Georgia, United States, 31210
        • Not yet recruiting
        • Site 118
    • Kentucky
      • Bowling Green, Kentucky, United States, 42103
        • Not yet recruiting
        • Site 122
    • Michigan
      • Flint, Michigan, United States, 48532
        • Not yet recruiting
        • Site 126
      • Livonia, Michigan, United States, 48152
        • Recruiting
        • Site 107
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • Site 108
    • New York
      • Niagara Falls, New York, United States, 14304
        • Not yet recruiting
        • Site 129
      • Orchard Park, New York, United States, 14127
        • Not yet recruiting
        • Site 120
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Not yet recruiting
        • Site 104
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Not yet recruiting
        • Site 124
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Site 100
      • Conroe, Texas, United States, 77384
        • Recruiting
        • Site 117
      • Edinburg, Texas, United States, 78539
        • Not yet recruiting
        • Site 128
      • El Paso, Texas, United States, 79935
        • Not yet recruiting
        • Site 127
      • Fort Worth, Texas, United States, 76132
        • Not yet recruiting
        • Site 106
      • Houston, Texas, United States, 77095
        • Not yet recruiting
        • Site 110
      • Humble, Texas, United States, 77346
        • Recruiting
        • Site 101
      • San Antonio, Texas, United States, 78233
        • Not yet recruiting
        • Site 116
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Not yet recruiting
        • Site 119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YB-101
In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
Drug: Experimental: YB-101
YB-101 is administered over a 24 week period.
Placebo Comparator: Placebo YB-101
In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.
Drug: Placebo YB-101
Placebo will be administered over a 24 week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time Frame: Baseline, Day 169
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
Baseline, Day 169

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yarrow Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YB-101-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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