Graves' DiseasePhase 2NCT07682896
Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
A Phase 2 study testing Experimental: YB-101 in people with Graves' Disease, run by Yarrow Bioscience, Inc. at 32 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Experimental: YB-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 10 Jun 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 2 countries
United States29 sites, 29 recruiting
- Recruiting
Site 100
Amarillo, Texas, 79124
- Recruiting
Site 122
Bowling Green, Kentucky, 42103
- Recruiting
Site 131
Cary, North Carolina, 27513
- Recruiting
Site 117
Conroe, Texas, 77384
- Recruiting
Site 133
Dallas, Texas, 75246
- Not yet recruiting
Site 134
Durham, North Carolina, 27713
- Recruiting
Site 128
Edinburg, Texas, 78539
- Recruiting
Site 127
El Paso, Texas, 79935
- Recruiting
Site 126
Flint, Michigan, 48532
- Recruiting
Site 106
Fort Worth, Texas, 76132
- Recruiting
Site 112
Gilbert, Arizona, 85297
- Recruiting
Site 110
Houston, Texas, 77095
- Recruiting
Site 101
Humble, Texas, 77346
- Recruiting
Site 121
La Mesa, California, 91942
- Recruiting
Site 107
Livonia, Michigan, 48152
- Recruiting
Site 118
Macon, Georgia, 31210
- Recruiting
Site 109
Miami Lakes, Florida, 33016
- Recruiting
Site 129
Niagara Falls, New York, 14304
- Not yet recruiting
Site 135
Ocoee, Florida, 34761
- Recruiting
Site 108
Omaha, Nebraska, 68198
- Recruiting
Site 120
Orchard Park, New York, 14127
- Recruiting
Site 115
Palm Harbor, Florida, 34684
- Not yet recruiting
Site 130
Phoenix, Arizona, 85006
- Recruiting
Site 103
Sacramento, California, 95817
- Not yet recruiting
Site 111
San Francisco, California, 94143
- Recruiting
Site 123
Sarasota, Florida, 34239
- Recruiting
Site 124
Sayre, Pennsylvania, 18840
- Recruiting
Site 105
Torrance, California, 90502
- Recruiting
Site 132
Tucson, Arizona, 85710
Australia3 sites, 3 recruiting
- Not yet recruiting
Site 151
East Melbourne, Victoria, 3002
- Not yet recruiting
Site 150
Melbourne N., Victoria, 3051
- Not yet recruiting
Site 153
St Leonards, New South Wales, 2065
About this study
Official 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
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.
- Conditions
- Graves' Disease
- Being tested
- Experimental: YB-101, Placebo YB-101
- Keywords
- Graves', Graves' Disease, Hyperthyroidism, Autoimmune thyroid disease, TSH receptor antibodies
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: YB-101Drug
YB-101 is administered over a 24 week period.
Placebo YB-101Drug
Placebo will be administered over a 24 week period.
| Study group | Role | What they receive |
|---|---|---|
| YB-101 | Experimental | In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection. Receives: Drug: Experimental: YB-101 |
| Placebo YB-101 | Placebo comparator | In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection. Receives: Drug: Placebo YB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Measured: 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
Measured: Baseline, Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yarrow Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682896
- Sponsor's protocol ID
- YB-101-201
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07682896
- Acronym / sponsor ID
- YB-101-201
- Conditions
- Graves' Disease
- Keywords
- Graves', Graves' Disease, Hyperthyroidism, Autoimmune thyroid disease, TSH receptor antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Yarrow Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YB-101 | Experimental | Drug: Experimental: YB-101In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection. |
| Placebo YB-101 | Placebo comparator | Drug: Placebo YB-101In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: YB-101YB-101 is administered over a 24 week period. | Drug | YB-101 |
| Placebo YB-101Placebo will be administered over a 24 week period. | Drug | Placebo YB-101 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental: YB-101 in people with Graves' Disease, run by Yarrow Bioscience, Inc. at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Lacasse, MD (469-278-6161, VL@YarrowBioscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) (time frame: Baseline, Day 169). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.