Recruiting

Phase 2

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

Sponsor:

Yarrow Bioscience, Inc.

Code:

NCT07682896

Conditions

Graves' Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental: YB-101

Placebo YB-101

Study Details

Brief 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.

Conditions

Graves' Disease

Study ID

NCT07682896

Start date

Jun 10, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

232 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

placebo comparator: Placebo YB-101

In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.

Interventions

Experimental: YB-101

YB-101 is administered over a 24 week period.

Placebo YB-101

Placebo will be administered over a 24 week period.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Victoria Lacasse, MD

469-278-6161 VL@YarrowBioscience.com

Locations

Site 112

Recruiting

Gilbert, Arizona, United States, 85297

Site 121

Recruiting

La Mesa, California, United States, 91942

Site 109

Recruiting

Miami Lakes, Florida, United States, 33016

Site 115

Recruiting

Palm Harbor, Florida, United States, 34684

Site 118

Recruiting

Macon, Georgia, United States, 31210

Site 122

Recruiting

Bowling Green, Kentucky, United States, 42103

Site 126

Recruiting

Flint, Michigan, United States, 48532

Site 107

Recruiting

Livonia, Michigan, United States, 48152

Site 129

Recruiting

Niagara Falls, New York, United States, 14304

Site 120

Recruiting

Orchard Park, New York, United States, 14127

Site 100

Recruiting

Amarillo, Texas, United States, 79124

Site 117

Recruiting

Conroe, Texas, United States, 77384

Site 128

Recruiting

Edinburg, Texas, United States, 78539

Site 106

Recruiting

Fort Worth, Texas, United States, 76132

Site 110

Recruiting

Houston, Texas, United States, 77095

Site 101

Recruiting

Humble, Texas, United States, 77346

Site 116

Recruiting

San Antonio, Texas, United States, 78233

More Information

Sponsor

Yarrow Bioscience, Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yarrow Bioscience, Inc. on 2026-09-04.