Actively Recruiting
A Phase 2 Trial Investigating the Safety, Tolerability and Efficacy of EXT608 in Adults With Hypoparathyroidism
Led by Extend Biosciences Inc. · Updated on 2025-05-25
35
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the safety, tolerability and efficacy of EXT608 in adults with hypoparathyroidism.
CONDITIONS
Official Title
A Phase 2 Trial Investigating the Safety, Tolerability and Efficacy of EXT608 in Adults With Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Willing and able to follow study procedures and restrictions
- Male or female aged 18 to 65 years
- Males with female partners of childbearing potential agree to use barrier contraception or abstain from heterosexual intercourse during and 3 months after treatment
- Females must be surgically sterile, postmenopausal, or if of childbearing potential, non-lactating and using effective birth control from 30 days before to 3 months after treatment
- History of hypoparathyroidism for at least 12 months with low PTH and serum calcium below 9 mg/dL
- Receiving daily calcium doses >750 mg if on >0.25 µg/day calcitriol, or >1000 mg if not on calcitriol
- Normal 25-hydroxyvitamin D blood levels (>20 ng/dL and ≤1.5 times upper normal limit)
- Normal thyroid tests for at least 3 months on stable thyroid medication or none
- Body mass index less than 35 kg/m2
- Albumin-adjusted serum calcium between the lower half and middle of normal range at randomization
You will not qualify if you...
- Hypoparathyroidism caused by calcium sensing receptor mutation or pseudohypoparathyroidism
- Other diseases affecting calcium or phosphorus metabolism or requiring parenteral calcium
- Unwilling to use a smartphone diary daily for vitamin D, calcium, magnesium, study drug doses and symptom reporting
- History of cancer except thyroid cancer without recurrence for 5 years
- History or active gastrointestinal disease affecting calcium absorption
- Severe hypocalcemia causing seizures or arrhythmias within 6 months
- Chronic kidney disease with eGFR less than 30 ml/min or active kidney stones needing pain medication in last 6 months
- Recent use of certain medications: proton pump inhibitors (within 4 weeks), bisphosphonates (3 months), parathyroid hormone/PTH analogs (6 months), thiazide diuretics (14 days), calcitonin or calcinet hydrochloride (3 months)
- Increased cardiac risk including QTcF >450 ms or abnormal PR interval, history of risk factors for Torsades de Pointes, or use of QT prolonging drugs
- Chronic or severe heart disease including heart failure, unstable angina, arrhythmias, slow heart rate (<60 bpm), or low blood pressure (systolic <100 mmHg or diastolic <60 mmHg)
- Any condition that may interfere with participation or safety interpretation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Trial Site
Buenos Aires, Buenos Aires F.D., Argentina, 1180AAX
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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