Graves DiseasePhase 2NCT06240455
Phase 2 Study to Assess Efficacy & Safety of WP1302 Prevent Relapse of MMI w/Draw in Subj. w/ Graves' dz
A Phase 2 study testing WP1302 and methimazole in people with Graves Disease, run by Worg Biotherapeutics Inc. at 7 sites in United States.
Trial summary
This is a Phase 2, double-blind, placebo controlled, Methimazole (MMI) withdrawal study in subjects with Graves' disease. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with Methimazole period of 12 weeks; a Full dose of WP1302 or placebo with Methimazole… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- WP1302 and methimazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Mar 2026to 30 Sep 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years at the time of informed consent.
- Confirmed diagnosis of Graves' disease through medical history and/or physical examination, laboratory evidence as documented by a serum TSH\<0.5 mU/L and either a serum total T3 \>180 ng/dL or a serum free T4 \> 1.8 ng/dL.
- Current use of MMI at stable dose not exceeding 20 mg daily for at least 8 weeks and no more than 24 weeks by the baseline (Week 0).
- 60 ng/dL \< serum total T3 ≤ 180 ng/dL, 0.8 ng/dL \< serum free T4 ≤1.8 ng/dL, and 0.5 mU/L ≤ serum TSH \<5 mU/L at the Screening Visit.
- Willing and able to give written informed consent, agree to provide contact with the endocrinologist (or other appropriate trained healthcare provider), and to comply with protocol assessments/procedures.
- Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study, and until at least 6 months after the last dose of WP1302.
- Female subjects of child-bearing potential must use a highly effective method of contraception throughout the entire duration of the study and for at least 6 months after the last dose of WP1302.
Who cannot join
- Currently using biotin supplements.
- Known history of allergy to the ingredients of WP1302, or hypersensitivity reaction that in the opinion of the investigator would exclude the subject's participation in the study.
- Previous treatment with radioiodine or (partial or complete) thyroidectomy.
- Subjects with known pituitary disease, such as traumatic brain disease, hyperprolactinemia, and hypophysitis.
- Treatment with steroids (administered via the oral and/or parenteral routes) within 3 months prior to baseline or requiring intermittent use of systemic steroids for disease management (such as severe asthma), inhaled steroids are not prohibited.
- History of hyperthyroidism not caused by Graves' disease (e.g., toxic multinodular goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis).
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- Subjects who may have thyroid nodules that require alternative intervention.
- Symptoms and signs of thyroid storm such as fever, profuse sweating, vomiting, diarrhea, delirium, severe weakness, seizures, markedly irregular heartbeat, yellow skin and eyes (jaundice), severe low blood pressure, and coma, pyrexia with no other cause than hyperthyroidism.
- Subjects who have a history of intolerance or contraindication to the use of beta-blockers.
- Subjects with history of arrhythmia, or cardiovascular accident, or other cardiovascular disease who maybe at increased risk of cardiac adverse events from treatment or recurrence of hyperthyroidism.
- Subjects with history of cerebrovascular accident/transient ischemic attack, or other cerebrovascular disease who maybe at increased risk of neurologic adverse events from treatment or recurrence of hyperthyroidism.
- Prior treatment with immunotherapies (including rituximab), any cytokine or anti-cytokine therapy.
- Prior treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, and/or cyclophosphamide.
- Prior use of disease-related T cell-inducing therapy or peptide-tolerizing agent to treat Graves' disease.
- Inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase \> 3 times the upper limits of the normal (ULN) at screening.
- Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2, calculated as individual eGFR derived from Modification of Diet in Renal Disease formula.
- Receiving hemodialysis or peritoneal dialysis or microdialysis or continuous venovenous hemofiltration or continuous venovenous hemodialysis.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Known history of active or chronic infectious disease or any disease which compromises immune function (e.g., HIV+, HTLV-1, active Lyme disease, latent or active TB, viral hepatitis).
- Major surgery within 6 months prior to the screening visit or requiring ongoing active treatment after surgery irrespective of the time since surgery.
- Active thyroid eye disease (clinical activity score [CAS] ≥3) with functional visual impairment sufficient to cause poor quality of life, or dysthyroid optic neuropathy likely to require immunosuppressive treatment during the 30 weeks of the study.
- Any vaccination within 30 days prior to screening, except for influenza and coronavirus vaccines.
- Being pregnant, breastfeeding, or planning to become pregnant during the study.
- Documented presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or known human immunodeficiency virus infection with a CD4 count \<200/mm3.
- Currently actively moderate-heavy using tobacco (≥10 cigarettes a day).
- Participating in any clinical study of any investigational medication (i.e., unauthorized medication) within 90 days prior to randomization.
- Any other significant medical illness or psychiatric conditions that in the opinion of the investigator, would preclude participation in the study or impair the ability to give informed consent; any other clinically apparent autoimmune disease currently requiring disease-modifying or anti-inflammatory treatment; or significant illness which has not resolved within 4 weeks prior to the planned date of first dose of WP1302.
- Any other conditions or prior therapies, which, in the opinion of the investigator, would make the subject unsuitable for this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Albuquerque Clinical Trials Inc
Albuquerque, New Mexico, 87102
Alliance Research Institute
Canoga Park, California, 22110
BayCare Health System, Inc.
Clearwater, Florida, 33759
Cleveland Clinic
Cleveland, Ohio, 44195
Clinical Research Solution LLC dba Endocrine and Psychiatry Center
Houston, Texas, 77095
East Valley Diabetes and Endocrinology-Clinical Research, PLLC
Hunt, Arizona, 85143
Paradigm Clinical Research Centers - Littleton
Littleton, Colorado, 80120
About this study
Official title: A Double-blind, Placebo-controlled, Phase 2 Dose-range Study to Assess the Efficacy and Safety of WP1302 in Preventing Disease Relapse Following Methimazole Withdrawal in Subjects With Graves' Disease
This is a Phase 2, double-blind, placebo controlled, Methimazole (MMI) withdrawal study in subjects with Graves' disease. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with Methimazole period of 12 weeks; a Full dose of WP1302 or placebo with Methimazole tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of Methimazole with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of Methimazole with placebo.
All the subjects will subsequently be enrolled in an extended safety follow-up period for an additional 6 months. Subjects who remain euthyroid will continue to be monitored for efficacy during the long-term follow-up.
Read the detailed description
This is a Phase 2, double-blind, placebo controlled, Methimazole (MMI) withdrawal study in subjects with Graves' disease. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with Methimazole period of 12 weeks; a full dose of WP1302 or placebo with Methimazole tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of Methimazole with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of Methimazole with placebo.
Subjects who have a confirmed diagnosis of Graves' disease based on medical history and/or physical examination and laboratory evidence, well controlled, with normalized thyroid function tests, and have received stable background Methimazole (i.e., not requiring dose adjustments) not exceeding 20 mg daily for at least 8 weeks and no more than 24 weeks are eligible to this study. All subjects enrolled in this study will receive Methimazole treatment in titration period.
During the titration period, subjects will receive WP1302 or placebo by subcutaneous (S.C.) injection every 2 weeks (Q2W) for 12 weeks while continuing MMI (see "Dosing" below). The dose of WP1302 will be titrated up to the target dose assigned to the subject during this period (see "Dosing" below). Thyroid symptoms and function tests will be evaluated every 2 weeks. The investigator may adjust the frequency of thyroid function tests based on safety considerations. If a subject does not maintain euthyroidism, which is defined as total T3 60-180 ng/dL, free T4 0.8-1.8 ng/dL, and TSH 0.5-5 mU/L, during the "WP1302 titration period", the subject will be discontinued from Investigational Medicinal Product (IMP) (i.e., WP1302 or placebo) and the subject is still required to complete the end-of study visit.
During the 26-week full dose of WP1302 with Methimazole tapering period, subjects who have maintained euthyroidism during the "WP1302 titration period" will be dosed with WP1302 at 400, 800, or 1200 μg with down-titrated Methimazole. Thyroid symptoms and function tests will be evaluated every 2 weeks. The investigator may adjust the frequency of thyroid function tests based on safety considerations. Subjects who experience disease relapse will be treated with Methimazole as first-line therapy (see "Management of Relapse and Rescue Medication" below).
At the end of the full dose of WP1302 with Methimazole tapering period, subjects will have 4 weeks of follow-up, and complete an end-of-study visit at Week 42. All the subjects will subsequently be enrolled in an extended safety follow-up period for an additional 6 months. Subjects who remain euthyroid will continue to be monitored for efficacy during the long-term follow-up.
- Conditions
- Graves Disease
- Being tested
- WP1302, WP1302 placebo, methimazole
- Keywords
- Graves' disease, preventing disease relapse, relapse rate, thyroid function
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WP1302Drug
Each arm will be treated with methimazole. During the MMI tapering period, commences the MMI weaning by reducing the original dosage by 50%. This adjusted dose is to be administered over a two-week duration. Continue this dose reduction in the subsequent 2-week durations until achieving a dose of 2.5 mg/day or lower. Upon reaching this threshold, MMI is to be discontinued (withdrawal).
WP1302 placeboDrug
Each arm will be treated with methimazole. During the MMI tapering period, commences the MMI weaning by reducing the original dosage by 50%. This adjusted dose is to be administered over a two-week duration. Continue this dose reduction in the subsequent 2-week durations until achieving a dose of 2.5 mg/day or lower. Upon reaching this threshold, MMI is to be discontinued (withdrawal).
methimazoleCombination product
Each arm will be treated with methimazole. During the MMI tapering period, commences the MMI weaning by reducing the original dosage by 50%. This adjusted dose is to be administered over a two-week duration. Continue this dose reduction in the subsequent 2-week durations until achieving a dose of 2.5 mg/day or lower. Upon reaching this threshold, MMI is to be discontinued (withdrawal).
| Study group | Role | What they receive |
|---|---|---|
| WP1302 400μg | Active comparator | After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo.
The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. Receives: Drug: WP1302; Combination Product: methimazole |
| WP1302 800μg | Active comparator | After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo.
The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. Receives: Drug: WP1302; Combination Product: methimazole |
| WP1302 1200μg | Active comparator | After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo.
The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. Receives: Drug: WP1302; Combination Product: methimazole |
| WP1302 Placebo | Placebo comparator | After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo.
The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. Receives: Drug: WP1302 placebo; Combination Product: methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
To assess the relapse rate between the WP1302 and placebo treatment groups in subjects who enter the tapering phase
Measured: Up to 42 weeks
Secondary outcomes (5)
Replase time
To assess the time duration from start of methimazole (MMI) tapering to disease relapse between the subjects treated with WP1302 and placebo.
Measured: Up to 42 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To assess the safety and tolerability of WP1302 administered with or without methimazole (MMI) in subjects with Graves' disease
Measured: Up to 68 weeks including LTFU
Total T3, free T4, and TSH levels
To assess the effect of WP1302 on thyroid function (measured by total T3, free T4, and TSH levels)
Measured: Up to 68 weeks including LTFU
Pharmacokinetics (PK) parameters (AUC, Cmax)
To assess the pharmacokinetics (PK) parameters (AUC, Cmax) of WP1302 in plasma
Measured: Week 0 and Week 10
Incidence of anti-drug antibodies (ADAs)
To assess the incidence of anti-drug antibodies (ADAs) against WP1302
Measured: Up to 68 weeks including LTFU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Why it stopped: Not feasible to recruit suitable subjects
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Worg Biotherapeutics Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dylan Lee, MD, Study chair, Worg Biotherapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240455
- Sponsor's protocol ID
- WP1302-CS-002
- Status last verified
- May 2025
- First submitted
- 4 Jan 2024
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Phase 2 Dose-range Study to Assess the Efficacy and Safety of WP1302 in Preventing Disease Relapse Following Methimazole Withdrawal in Subjects With Graves' Disease
- ClinicalTrials.gov ID
- NCT06240455
- Acronym / sponsor ID
- WP1302-CS-002
- Conditions
- Graves Disease
- Keywords
- Graves' disease, preventing disease relapse, relapse rate, thyroid function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not feasible to recruit suitable subjects
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Worg Biotherapeutics Inc.University, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 5 Feb 2024 (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 is a Phase 2, double-blind, placebo controlled, Methimazole (MMI) withdrawal study in subjects with Graves' disease. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with Methimazole period of 12 weeks; a Full dose of WP1302 or placebo with Methimazole tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of Methimazole with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of Methimazole with placebo.
All the subjects will subsequently be enrolled in an extended safety follow-up period for an additional 6 months. Subjects who remain euthyroid will continue to be monitored for efficacy during the long-term follow-up.
Detailed description
This is a Phase 2, double-blind, placebo controlled, Methimazole (MMI) withdrawal study in subjects with Graves' disease. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with Methimazole period of 12 weeks; a full dose of WP1302 or placebo with Methimazole tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of Methimazole with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of Methimazole with placebo.
Subjects who have a confirmed diagnosis of Graves' disease based on medical history and/or physical examination and laboratory evidence, well controlled, with normalized thyroid function tests, and have received stable background Methimazole (i.e., not requiring dose adjustments) not exceeding 20 mg daily for at least 8 weeks and no more than 24 weeks are eligible to this study. All subjects enrolled in this study will receive Methimazole treatment in titration period.
During the titration period, subjects will receive WP1302 or placebo by subcutaneous (S.C.) injection every 2 weeks (Q2W) for 12 weeks while continuing MMI (see "Dosing" below). The dose of WP1302 will be titrated up to the target dose assigned to the subject during this period (see "Dosing" below). Thyroid symptoms and function tests will be evaluated every 2 weeks. The investigator may adjust the frequency of thyroid function tests based on safety considerations. If a subject does not maintain euthyroidism, which is defined as total T3 60-180 ng/dL, free T4 0.8-1.8 ng/dL, and TSH 0.5-5 mU/L, during the "WP1302 titration period", the subject will be discontinued from Investigational Medicinal Product (IMP) (i.e., WP1302 or placebo) and the subject is still required to complete the end-of study visit.
During the 26-week full dose of WP1302 with Methimazole tapering period, subjects who have maintained euthyroidism during the "WP1302 titration period" will be dosed with WP1302 at 400, 800, or 1200 μg with down-titrated Methimazole. Thyroid symptoms and function tests will be evaluated every 2 weeks. The investigator may adjust the frequency of thyroid function tests based on safety considerations. Subjects who experience disease relapse will be treated with Methimazole as first-line therapy (see "Management of Relapse and Rescue Medication" below).
At the end of the full dose of WP1302 with Methimazole tapering period, subjects will have 4 weeks of follow-up, and complete an end-of-study visit at Week 42. All the subjects will subsequently be enrolled in an extended safety follow-up period for an additional 6 months. Subjects who remain euthyroid will continue to be monitored for efficacy during the long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WP1302 400μg | Active comparator | Drug: WP1302, Combination Product: methimazoleAfter screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. |
| WP1302 800μg | Active comparator | Drug: WP1302, Combination Product: methimazoleAfter screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. |
| WP1302 1200μg | Active comparator | Drug: WP1302, Combination Product: methimazoleAfter screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. |
| WP1302 Placebo | Placebo comparator | Drug: WP1302 placebo, Combination Product: methimazoleAfter screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years at the time of informed consent.
- Confirmed diagnosis of Graves' disease through medical history and/or physical examination, laboratory evidence as documented by a serum TSH\<0.5 mU/L and either a serum total T3 \>180 ng/dL or a serum free T4 \> 1.8 ng/dL.
- Current use of MMI at stable dose not exceeding 20 mg daily for at least 8 weeks and no more than 24 weeks by the baseline (Week 0).
- 60 ng/dL \< serum total T3 ≤ 180 ng/dL, 0.8 ng/dL \< serum free T4 ≤1.8 ng/dL, and 0.5 mU/L ≤ serum TSH \<5 mU/L at the Screening Visit.
- Willing and able to give written informed consent, agree to provide contact with the endocrinologist (or other appropriate trained healthcare provider), and to comply with protocol assessments/procedures.
Key exclusion criteria (28 listed)
- Currently using biotin supplements.
- Known history of allergy to the ingredients of WP1302, or hypersensitivity reaction that in the opinion of the investigator would exclude the subject's participation in the study.
- Previous treatment with radioiodine or (partial or complete) thyroidectomy.
- Subjects with known pituitary disease, such as traumatic brain disease, hyperprolactinemia, and hypophysitis.
- Treatment with steroids (administered via the oral and/or parenteral routes) within 3 months prior to baseline or requiring intermittent use of systemic steroids for disease management (such as severe asthma), inhaled steroids are not prohibited.
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 |
|---|---|---|
| WP1302Each arm will be treated with methimazole. During the MMI tapering period, commences the MMI weaning by reducing the original dosage by 50%. This adjusted dose is to be administered over a two-week duration. Continue this dose reduction in the subsequent 2-week durations until achieving a dose of 2.5 mg/day or lower. Upon reaching this threshold, MMI is to be discontinued (withdrawal). | Drug | WP1302 1200μg, WP1302 400μg, WP1302 800μg |
| WP1302 placeboEach arm will be treated with methimazole. During the MMI tapering period, commences the MMI weaning by reducing the original dosage by 50%. This adjusted dose is to be administered over a two-week duration. Continue this dose reduction in the subsequent 2-week durations until achieving a dose of 2.5 mg/day or lower. Upon reaching this threshold, MMI is to be discontinued (withdrawal). | Drug | WP1302 Placebo |
| methimazoleEach arm will be treated with methimazole. During the MMI tapering period, commences the MMI weaning by reducing the original dosage by 50%. This adjusted dose is to be administered over a two-week duration. Continue this dose reduction in the subsequent 2-week durations until achieving a dose of 2.5 mg/day or lower. Upon reaching this threshold, MMI is to be discontinued (withdrawal). | Combination product | WP1302 1200μg, WP1302 400μg, WP1302 800μg, WP1302 Placebo |
Primary outcome
Relapse rate
Time frame: Up to 42 weeks
To assess the relapse rate between the WP1302 and placebo treatment groups in subjects who enter the tapering phase
5 secondary outcomes
Replase time
Time frame: Up to 42 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 68 weeks including LTFU
Total T3, free T4, and TSH levels
Time frame: Up to 68 weeks including LTFU
Pharmacokinetics (PK) parameters (AUC, Cmax)
Time frame: Week 0 and Week 10
Incidence of anti-drug antibodies (ADAs)
Time frame: Up to 68 weeks including LTFU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- 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. This study is not recruiting at the moment.
Dylan Lee, MD study chair
Worg Biotherapeutics Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WP1302 and methimazole in people with Graves Disease, run by Worg Biotherapeutics Inc. at 7 sites in United States.
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 7 inclusion and 28 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: paused, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: Up to 42 weeks). 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 8 May 2025.