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Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism

Efficacy and Safety of mRNA Drug XH02 in the Treatment of Adult Hypoparathyroidism

NCT07197450•Peking Union Medical College Hospital

Summary

This study aims to evaluate the safety and efficacy of a novel PTH replacement therapy drug in patients with hypoparathyroidism. The drug is an mRNA drug which will be translated into PTH after intravenous administration, to achieve the therapeutic effect.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18 to 65 years (inclusive), male or female.
•Documented history of post-surgical chronic HP or autoimmune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is confirmed based on a history of hypocalcemia accompanied by an inappropriately low serum PTH level (below the upper limit of the normal range of the local laboratory). \* Note: If a subject lacks documented diagnosis of chronic HP but has exhibited hypocalcemia accompanied by an inappropriately low serum PTH level for at least 26 weeks prior to screening, and is judged by the investigator to meet the diagnostic criteria for chronic HP, they will be considered eligible for this criterion.
•Poorly controlled or intolerant to conventional therapy (calcium and active vitamin D).
•Conventional therapy (including vitamin D or magnesium supplements, if applicable) can be optimized during the screening period to achieve the following target serum levels: 25(OH) Vitamin D level: 10 - 100 ng/mL (25 - 250 nmol/L, inclusive). Blood magnesium level: Within the normal range or slightly below, i.e., ≥ 1.3 mg/dL (≥ 0.53 mmol/L). Albumin-corrected serum calcium (sCa) level: Within the normal range or slightly below
•Body Mass Index (BMI) of 17 to 40 kg/m² (inclusive) at screening.
•If aged ≤ 25 years, radiological evidence of closed epiphyses based on X-ray of the non-dominant hand (wrist and palm).

Exclusion Criteria

•Impaired PTH response (pseudohypoparathyroidism), characterized by PTH resistance and elevated PTH levels in the presence of hypocalcemia.
•History of allergic predisposition, or known allergy to the investigational drug or polyethylene glycol (PEG)-containing medications.
•Any disease other than HP that may affect calcium metabolism, calcium-phosphate homeostasis, or PTH levels, such as: active hyperthyroidism; Paget's disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes (HbA1c \>9%; HbA1c results from within 12 weeks prior to screening are acceptable); severe and chronic liver or kidney disease; Cushing's syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobilization; active malignancy (except for low-risk, well-differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; history of parathyroid carcinoma within 5 years prior to screening; acromegaly; or multiple endocrine neoplasia syndromes.
•History of vaccination within 4 weeks prior to enrollment, or planned vaccination during the study period.
•Pregnant or lactating women.
•Patients with high-risk thyroid cancer requiring TSH suppression \<0.2 mIU/L within the past 2 years, or patients with a history of malignancy.
•Requirement for long-term use of the following medications: diuretics, phosphate binders (except calcium supplements), digoxin, lithium, methotrexate, biotin \>30 μg/day, or systemic corticosteroids (except as replacement therapy). Patients requiring long-term use of hormones or immunosuppressants (e.g., for rheumatologic/autoimmune diseases) are excluded. \*Note: Subjects who can discontinue these medications for the study may be enrolled, provided the medications are stopped for at least 5.5 half-lives prior to blood sampling at Visit 1. Biotin must be stopped for at least 1 day prior to blood sampling during the screening period. These medications are prohibited throughout the entire study.\*
•Use of PTH-like drugs (whether commercially available or obtained through participation in a clinical trial), including PTH(1-84), PTH(1-34), other N-terminal fragments or analogs of PTH, or PTH-related protein, within 4 weeks prior to screening.
•Participation in any other interventional trial involving an investigational drug or device within 8 weeks prior to screening, or within 5.5 half-lives of the administered drug from the previous trial (whichever is longer).
•Uncontrolled hypertension at baseline, OR a history of the following cardiovascular and cerebrovascular diseases: (1) Unstable angina; (2) Drug-requiring or severe arrhythmia; (3) Myocardial infarction; (4) Class III or higher heart failure (NYHA classification), or second-degree or higher atrioventricular block; (5) Cerebral infarction (except lacunar infarction), cerebral hemorrhage, or related diseases.
+5 more criteria

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Key Dates

Start Date

May 20, 2025

Primary Completion Date

December 31, 2025

Completion Date

March 31, 2026

Last Updated

December 9, 2025

Enrollment

ESTIMATED participants

Conditions

Hypoparathyroidism

Interventions

intravenous administration of PTH1-84 mRNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism

Inclusion Criteria

Exclusion Criteria

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