NCT06465108|CompletedPhase 2FDA Drug

Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)

MBX Biosciences ClinicalTrials.gov

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1 other identifier

MBX-2H1002

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredJun 2024

StartedAug 2024

CompletionJun 2025

Brief Summary

The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Aug 2024

Shorter than P25 for phase_2

Geographic Reach

3 countries

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

June 13, 2024

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

August 8, 2024

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2025

Completed

12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

June 13, 2024

Last Update Submit

March 17, 2026

Conditions

Hypoparathyroidism

Keywords

HypoparathyroidHypoparaThyroidMBX 2109

Outcome Measures

Primary Outcomes (1)

To evaluate the effect of pooled weekly doses of MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12/Visit 15
Proportion of patients pooled across MBX 2109 doses meeting the composite criteria at week 12/Visit 15 * Independence from active vitamin D supplements * Oral elemental calcium doses of ≤600 mg/day * Serum albumin-adjusted calcium (AdjCa) values of 8.2 to 10.6 mg/dL
Week 12

Study Arms (4)

Starting dose of 400 µg once-weekly by subcutaneous injection

EXPERIMENTAL

Drug: MBX 2109

Starting dose of 600 µg once-weekly by subcutaneous injection

EXPERIMENTAL

Drug: MBX 2109

Starting dose of 800 µg once-weekly by subcutaneous injection

EXPERIMENTAL

Drug: MBX 2109

Placebo - once-weekly by subcutaneous injection

PLACEBO COMPARATOR

Other: Placebo

Interventions

MBX 2109DRUG

Supplied as 1.5 mg per vial reconstituted in 1.4 mL water for injection to a concentration of 1.0 mg/mL

Also known as: Canvuparatide

Starting dose of 400 µg once-weekly by subcutaneous injectionStarting dose of 600 µg once-weekly by subcutaneous injectionStarting dose of 800 µg once-weekly by subcutaneous injection

PlaceboOTHER

Supplied in 1.4 mL water for injection

Placebo - once-weekly by subcutaneous injection

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Is an adult ≥18 years of age at the time of the Screening visit.
a. If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of non-dominant wrist and hand
Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the Screening visit:
Postsurgical chronic hypoparathyroidism
Idiopathic hypoparathyroidism
Autoimmune hypoparathyroidism (e.g., isolated autoimmune hypoparathyroidism; stable, well-managed patients with autoimmune polyglandular syndrome type 1/autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy without current or past malabsorption at the discretion of the principal investigator \[PI\])
On a dose for at least 4 weeks prior to the Screening visit of the following:
Calcitriol ≥0.5 µg per day or alfacalcidol ≥1 ug per day (active vitamin D)
Elemental calcium (citrate or carbonate) supplement ≥800 mg per day
a) If the patient had a history of hypercalcemia on the above active vitamin D and/or calcium doses, the patient may be eligible to participate in the study on lower doses of calcitriol, alfacalcidol and/or elemental calcium with approval of the medical monitor
At the Screening visit or at completion of the Optimization Period, the following serum analytes must be within the following ranges:
AdjCa: 8.2 to 10.6 mg/dL (2.05 to 2.65 mmol/L), inclusive, targeting the lower half of the reference range
(OH)D: 30 to 64 ng/mL (75 to 160 nmol/L), inclusive
Magnesium: within the normal range of 1.8 to 2.6 mg/dL (0.65 to 1.05 mmol/L; 1.3 mEq/L to 2.1 mEq/L), inclusive; if the patient had a history of not being successful in maintaining serum magnesium within the normal reference range, a level slightly below the normal range (≥1.3 mg/dL \[≥0.53 mmol/L\]) may be acceptable with approval by the medical monitor 1.3 mEq/L to 2.1 mEq/L), inclusive
Has an estimated glomerular filtration rate \>60 mL/min/1.73 m2, as estimated using the Chronic Kidney Disease Epidemiology Collaboration equation, at the Screening visit.
+2 more criteria

You may not qualify if:

Has a known history of pseudohypoparathyroidism (impaired responsiveness to PTH, which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia).
Use any of the following therapies:
Loop diuretics, thiazide diuretics, phosphate binders (other than calcium carbonate or citrate), digoxin, lithium, methotrexate, raloxifene hydrocholoride, or acute systemic corticosteroids within 4 weeks prior to the Screening Visit;
Chronic systemic corticosteroid use is allowed if the dose has been stable for 4 weeks prior to Screening visit
PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 4 weeks of the Screening visit;
Oral or intravenous bisphosphonates, denosumab, or romosozumab-aqqg within 18 months of the Screening visit; or
Other drugs known to influence calcium and bone metabolism such as calcitonin, fluoride tablets (\>0.5 mg per day), strontium or cinacalcet hydrochloride within 3 months of the Screening visit.
Is at an increased risk for osteosarcoma (e.g., Paget's disease, prior history of substantial external beam or implant radiation therapy involving the skeleton, unexplained elevations of alkaline phosphatase)
Is affected by active or uncontrolled disease processes that may adversely affect gastrointestinal absorption at the discretion of the PI.
Has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than differentiated thyroid cancer, basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 2 years from the Screening visit.
Has any clinically significant cardiovascular disease within 6 months prior to the Screening visit such as symptomatic heart failure, an acute coronary syndrome, uncontrolled arrhythmia, or cerebrovascular accident.
Has a clinically significant abnormal 12-lead ECG in the opinion of the investigator at the Screening visit suggestive of underlying cardiac disease.
Has a seated systolic blood pressure \<100 mmHg or \>165 mmHg and/or diastolic blood pressure \>100 mmHg at the Screening visit. If outside this range, measurement can be repeated on another day for eligibility purposes within the Screening Period. If on medications for hypertension, the doses should be stable for 4 weeks prior to the Screening visit.
Has a history of symptomatic nephrolithiasis within 3 months of the Screening visit.
Has an episode of acute gout within 2 months of the Screening visit.
+9 more criteria

Contact the study team to confirm eligibility.