59 Participants Needed

TransCon PTH for Hypoparathyroidism

(PaTH Forward Trial)

Recruiting at 14 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ascendis Pharma A/S
Must be taking: Active vitamin D, Calcium
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests TransCon PTH, an injectable medication, on patients who might benefit from PTH treatment. It helps regulate calcium levels in the body, which is important for bone health and other functions. TransCon PTH is designed to overcome limitations of existing treatments.

Who Is on the Research Team?

AS

Aimee Shu, MD

Principal Investigator

Ascendis Pharma A/S Medical Monitor/Medical Expert

Are You a Good Fit for This Trial?

Adults over 18 with chronic hypoparathyroidism (HP) for at least half a year, taking specific vitamin D and calcium supplements, can join this trial. They must be able to self-inject medication and not have certain genetic mutations or recent use of related drugs. Pregnant women, those with severe heart or kidney issues, drug/alcohol dependence, or other conditions affecting calcium metabolism are excluded.

Inclusion Criteria

My kidney function is good.
Your body mass index (BMI) is between 17 and 40, which is a measure of your weight in relation to your height.
25(OH) vitamin D levels of 30-70 ng/mL (75-175 pmol/mL) and
See 14 more

Exclusion Criteria

I haven't taken drugs affecting bone metabolism like calcitonin or fluoride in the last 12 weeks.
My genetic test shows a mutation in the CaSR gene.
I don't have any health issues that could stop me from finishing the trial or that would make the trial unsafe for me.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either TransCon PTH or placebo for four weeks, administered as a subcutaneous injection using a pre-filled injection pen

4 weeks

Open-label extension

Participants receive open-label TransCon PTH with dose adjustments based on individual needs for up to 262 weeks

262 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo for TransCon PTH
  • TransCon PTH
Trial Overview The trial is testing TransCon PTH against a placebo in adults with HP. Initially, participants are randomly assigned to receive either the drug or placebo via injection without knowing which one they're getting. After four weeks, all move on to receive TransCon PTH tailored to their needs in an extension study.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Placebo Group
Group I: TransCon PTH 21 mcgExperimental Treatment1 Intervention
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
Group II: TransCon PTH 18 mcgExperimental Treatment1 Intervention
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
Group III: TransCon PTH 15 mcgExperimental Treatment1 Intervention
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
Group IV: Open-Label Extension PeriodExperimental Treatment1 Intervention
Subjects who complete the four-week blinded period are assigned to open-label treatment with TransCon PTH for up to 262 weeks, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized dosing.
Group V: PlaceboPlacebo Group1 Intervention
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ascendis Pharma A/S

Lead Sponsor

Trials
15
Recruited
1,600+
Unbiased ResultsWe believe in providing patients with all the options.
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