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Parathyroid Hormone Analog
Eneboparatide for Hypoparathyroidism (CALYPSO Trial)
Phase 3
Recruiting
Research Sponsored by Amolyt Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
CALYPSO Trial Summary
This trial will test if eneboparatide is a safe and effective treatment for cHP. Patients will receive a pre-filled pen with either eneboparatide or placebo and results will be tested over 24 weeks.
Who is the study for?
Adults aged 18-80 with chronic hypoparathyroidism, requiring daily treatments for calcium and vitamin D intake. Participants must be able to self-inject medication or have someone who can do it for them, not be pregnant or breastfeeding, and have stable health without conditions that affect calcium metabolism. They should also not have had recent seizures or certain cancer treatments.Check my eligibility
What is being tested?
The trial is testing eneboparatide (AZP-3601) against a placebo in patients with chronic hypoparathyroidism over a period of 52 weeks. Initially, participants won't know if they're receiving the actual drug or a placebo. After 24 weeks, all will receive eneboparatide in an open label extension phase.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, changes in blood pressure or heart rate, abnormal blood tests related to organ function, and possibly other symptoms associated with hormone therapies.
CALYPSO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy - Primary Endpoint
Secondary outcome measures
Change from baseline in the HPT-DD-SE - Cognitive Domain score
Change from baseline in the HPT-DD-SE - Physical Domain score
Change from baseline in the HPT-LIQ - Physical Functioning Domain score
+2 moreCALYPSO Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: eneboparatideExperimental Treatment1 Intervention
Starting dose of 20 mcg; Administered once daily by subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Administered once daily by subcutaneous injection
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Who is running the clinical trial?
Amolyt PharmaLead Sponsor
1 Previous Clinical Trials
132 Total Patients Enrolled
Soraya Allas, MDStudy DirectorAmolyt Pharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses that could affect my stomach or intestines.I have not taken oral bisphosphonates in the last 6 months or IV bisphosphonates in the last year.I have had a gout attack in the last 2 months.I have not had radiation to my bones in the last 2 years.I am between 18 and 80 years old.I have not had an uncontrolled cancer in the last 2 years.I haven't taken certain medications like water pills, lithium, methotrexate, heart medicine, or steroids in the last 4 weeks.I have had a seizure in the last 6 months due to epilepsy.I have a genetic condition affecting my calcium levels or response to parathyroid hormone.My calcium levels are stable with minimal changes in my vitamin D and calcium supplement doses.I haven't taken any parathyroid hormone-like drugs in the last 3 months.I don't have any conditions affecting my calcium or PTH levels, except hypoparathyroidism.I need IV calcium infusions to keep my calcium levels stable.I have used denosumab in the last 18 months.I understand and can follow the study's requirements.I don't have any health issues that could stop me from completing the trial or that would make the trial unsafe for me.I am at high risk for bone cancer.I have had a stroke in the last 6 months.I have been cancer-free for at least 2 years, except for thyroid or certain skin cancers.I haven't taken drugs affecting bone metabolism in the last 4 weeks.I am not able to have children or I am using birth control.My kidney function is at a safe level for the trial.I have had controlled high blood pressure for at least 12 months.I have had painful kidney stones in the last 3 months.I need daily calcitriol or alphacalcidol and extra calcium beyond my diet.I can give myself daily injections or have someone who can.
Research Study Groups:
This trial has the following groups:- Group 1: eneboparatide
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do candidates younger than 35 years old qualify for this scientific research?
"The participants of this medical trial should be between the ages 18 and 80. There are also separate studies available for those under 18, as well as 39 additional trials catered to patients over 65."
Answered by AI
What criteria must individuals meet in order to participate in this experiment?
"This clinical trial, which is seeking 165 participants, requires that patients have hypoparathyroidism and are within the ages of eighteen to eighty."
Answered by AI
Are the researchers presently looking for participants to join this investigation?
"Unfortunately, according to the clinicaltrials.gov database, this medical trial is no longer enrolling participants. The project was initially posted on June 1st 2023 and had its last update on March 9th 2023. Fortunately, there are currently 60 other studies seeking volunteers for their research efforts."
Answered by AI
Has the Federal Drug Administration officially sanctioned eneboparatide?
"The safety score of eneboparatide was set to 3 due to the existence of prior clinical data suggesting efficacy and multiple studies that affirm its security."
Answered by AI
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