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NCT07682896PHASE2Recruiting

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

Yarrow Bioscience, Inc.

Start Date

6/10/2026

Completion Date

9/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Experimental: YB-101

DRUG

Placebo YB-101

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Conditions

Graves' Disease

Locations

Site 112

Gilbert, Arizona 85297

United States

Site 130

Phoenix, Arizona 85006

United States

Site 121

La Mesa, California 91942

United States

Site 103

Sacramento, California 95817

United States

Site 111

San Francisco, California 94143

United States

Site 105

Torrance, California 90502

United States

Site 109

Miami Lakes, Florida 33016

United States

Site 115

Palm Harbor, Florida 34684

United States

Site 123

Sarasota, Florida 34239

United States

Site 118

Macon, Georgia 31210

United States

Site 122

Bowling Green, Kentucky 42103

United States

Site 126

Flint, Michigan 48532

United States

Site 107

Livonia, Michigan 48152

United States

Site 108

Omaha, Nebraska 68198

United States

Site 129

Niagara Falls, New York 14304

United States

Site 120

Orchard Park, New York 14127

United States

Site 124

Sayre, Pennsylvania 18840

United States

Site 100

Amarillo, Texas 79124

United States

Site 117

Conroe, Texas 77384

United States

Site 128

Edinburg, Texas 78539

United States

Site 127

El Paso, Texas 79935

United States

Site 106

Fort Worth, Texas 76132

United States

Site 110

Houston, Texas 77095

United States

Site 101

Humble, Texas 77346

United States

Site 116

San Antonio, Texas 78233

United States

Site 119

Chesapeake, Virginia 23321

United States

Site 151

East Melbourne, Victoria 3002

Australia

Site 150

Melbourne N., Victoria 3051

Australia