ClinicalTrials.gg
RecruitingNCT07682896Updated Oct 30, 2026

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

A Phase 2 interventional study of Experimental: YB-101 and Placebo YB-101 in Graves' Disease, sponsored by Yarrow Bioscience, Inc.. Recruiting at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Yarrow Bioscience, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Updated Oct 30, 2026Site recruiting status changed6 sites added+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Graves' Disease

Keywords

  • Graves'
  • Graves' Disease
  • Hyperthyroidism
  • Autoimmune thyroid disease
  • TSH receptor antibodies
03

In context

Graves Disease

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's planned enrollment of 232 is above the median of 60 across 104 interventional studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

This is the only study on the registry with Yarrow Bioscience, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
232 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugExperimental: YB-101

    YB-101 is administered over a 24 week period.

  • DrugPlacebo YB-101

    Placebo will be administered over a 24 week period.

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Day 169

  2. 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

07

Study locations

25 of 32 sites recruiting
  • Site 112
    Gilbert, Arizona 85297, United States
    Recruiting
  • Site 130
    Phoenix, Arizona 85006, United States
    Not yet recruiting
  • Site 132
    Tucson, Arizona 85710, United States
    Recruiting
  • Site 121
    La Mesa, California 91942, United States
    Recruiting
  • Site 103
    Sacramento, California 95817, United States
    Recruiting
  • Site 111
    San Francisco, California 94143, United States
    Not yet recruiting
  • Site 105
    Torrance, California 90502, United States
    Recruiting
  • Site 109
    Miami Lakes, Florida 33016, United States
    Recruiting
  • Site 135
    Ocoee, Florida 34761, United States
    Not yet recruiting
  • Site 115
    Palm Harbor, Florida 34684, United States
    Recruiting
  • Site 123
    Sarasota, Florida 34239, United States
    Recruiting
  • Site 118
    Macon, Georgia 31210, United States
    Recruiting
  • Site 122
    Bowling Green, Kentucky 42103, United States
    Recruiting
  • Site 126
    Flint, Michigan 48532, United States
    Recruiting
  • Site 107
    Livonia, Michigan 48152, United States
    Recruiting
  • Site 108
    Omaha, Nebraska 68198, United States
    Recruiting
  • Site 129
    Niagara Falls, New York 14304, United States
    Recruiting
  • Site 120
    Orchard Park, New York 14127, United States
    Recruiting
  • Site 131
    Cary, North Carolina 27513, United States
    Recruiting
  • Site 134
    Durham, North Carolina 27713, United States
    Not yet recruiting
  • Site 124
    Sayre, Pennsylvania 18840, United States
    Recruiting
  • Site 100
    Amarillo, Texas 79124, United States
    Recruiting
  • Site 117
    Conroe, Texas 77384, United States
    Recruiting
  • Site 133
    Dallas, Texas 75246, United States
    Recruiting
  • Site 128
    Edinburg, Texas 78539, United States
    Recruiting
  • Site 127
    El Paso, Texas 79935, United States
    Recruiting
  • Site 106
    Fort Worth, Texas 76132, United States
    Recruiting
  • Site 110
    Houston, Texas 77095, United States
    Recruiting
  • Site 101
    Humble, Texas 77346, United States
    Recruiting
  • Site 153
    St Leonards, New South Wales 2065, Australia
    Not yet recruiting
  • Site 151
    East Melbourne, Victoria 3002, Australia
    Not yet recruiting
  • Site 150
    Melbourne N., Victoria 3051, Australia
    Not yet recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2026
First posted
Jul 6, 2026
StartActual
Jun 10, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Sep 2029
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
6 sites added, 4 sites removed. 6 sites changed recruiting status (6 now recruiting)
Show 6 sites
  • Site 105 · Torrance, United StatesNot yet recruiting→Recruiting
  • Site 108 · Omaha, United StatesNot yet recruiting→Recruiting
  • Site 127 · El Paso, United StatesNot yet recruiting→Recruiting
  • Site 103 · Sacramento, United StatesNot yet recruiting→Recruiting
  • Site 123 · Sarasota, United StatesNot yet recruiting→Recruiting
  • Site 124 · Sayre, United StatesNot yet recruiting→Recruiting
Show 6 added (5 United States, 1 Australia)
  • Site 132 · Tucson, United States
  • Site 131 · Cary, United States
  • Site 133 · Dallas, United States
  • Site 135 · Ocoee, United States
  • Site 134 · Durham, United States
  • Site 153 · St Leonards, Australia
Show 4 removed
  • Clinical Research Site · Tucson, United States
  • Clinical Research Site · Raleigh, United States
  • Clinical Research Site · Dallas, United States
  • Site 116 · San Antonio, United States
across 2 updates, Oct 5, 2026 – Oct 30, 2026
Show all 2 updates
  1. Oct 30, 2026
    3 sites added. 3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Site 103 · Sacramento, United StatesNot yet recruiting→Recruiting
    • Site 123 · Sarasota, United StatesNot yet recruiting→Recruiting
    • Site 124 · Sayre, United StatesNot yet recruiting→Recruiting
    Show 3 added (2 United States, 1 Australia)
    • Site 135 · Ocoee, United States
    • Site 134 · Durham, United States
    • Site 153 · St Leonards, Australia
  2. Oct 5, 2026
    3 sites added, 4 sites removed. 3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Site 105 · Torrance, United StatesNot yet recruiting→Recruiting
    • Site 108 · Omaha, United StatesNot yet recruiting→Recruiting
    • Site 127 · El Paso, United StatesNot yet recruiting→Recruiting
    Show 3 added (3 United States)
    • Site 132 · Tucson, United States
    • Site 131 · Cary, United States
    • Site 133 · Dallas, United States
    Show 4 removed
    • Clinical Research Site · Tucson, United States
    • Clinical Research Site · Raleigh, United States
    • Clinical Research Site · Dallas, United States
    • Site 116 · San Antonio, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07682896
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Jun 10, 2026
Primary completion
Dec 2027 (estimated)
Completion
Sep 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Victoria Lacasse, MD
Contact
VL@YarrowBioscience.com
469-278-6161

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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