New synthetic hormone shows promise for rare calcium disorder
NCT ID NCT05239221
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tested a synthetic parathyroid hormone analog called AZP-3601 in healthy volunteers and patients with chronic hypoparathyroidism, a condition where the body doesn't produce enough parathyroid hormone. The study aimed to check safety and how the drug works in the body. It involved 132 participants across three parts, including single and multiple doses over up to three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZP-3601 (eneboparatide), a synthetic parathyroid hormone analog
- What this could lead to
- If successful, this could lead to a new treatment option for chronic hypoparathyroidism that helps control calcium levels and reduces symptoms.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with small groups and short treatment duration. The drug may not prove effective or safe in larger, longer studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
132 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
Aug 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main inclusion criteria * Part A: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2 * Part B: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a Body mass index of 19 to 28 kg/m2 * Part C: 1. Male and female patients aged 18 to 75 years inclusive 2. History of cHP for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (PTH). 3. Requirement for therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day (both are active vitamin D supplements), and requirement for supplemental oral calcium treatment ≥1000 mg per day over and above normal dietary calcium intake at baseline assessments. Main exclusion criteria * Parts A and B: 1. Clinically significant abnormal lab values, as judged by the investigator 2. Using tobacco products with 3 months prior to first drug administration 3. History of alcohol abuse or drug addiction * Part C: 1. Known history of autosomal-dominant hypocalcemia (ADH resulting from gain-of-function calcium-sensing receptor \[CaSR\] or GNA11 mutations) or pseudohypoparathyroidism (impaired responsiveness to PTH) 2. Any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than HP 3. Use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides (e.g., digoxin or digitoxin) or systemic corticosteroids within 4 weeks prior to start of treatment. 4. Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34), or abaloparatide, within 3 months prior to screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Amolyt Pharma Investigational Site Hungary
Budapest, Hungary
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PRA-EDS
Groningen, 9728, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.