A study to evaluate the efficacy and safety of AZP-3601 in patients with chronic hypoparathyroidism
Research type
Research Study
Full title
A PHASE 3 MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ENEBOPARATIDE (AZP-3601), A PARATHYROID HORMONE RECEPTOR AGONIST, IN PATIENTS WITH CHRONIC HYPOPARATHYROIDISM (CALYPSO)
IRAS ID
1007490
Contact name
Gaëlle Charier
Contact email
Sponsor organisation
Amolyt Pharma
Eudract number
2022-503126-12
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 research study of the experimental medication eneboparatide, in participants with chronic hypoparathyroidism (HP), a rare disease characterized by the absence or low level of parathyroid hormone (PTH) in the blood. PTH regulates the balance of calcium and phosphorous in the body. Eneboparatide is intended to mimic the activity of the naturally occurring PTH and help sustain normal blood and urine calcium levels. The study has 2 consecutives parts, the “Main Treatment period” and the “Open Label Extension (OLE) period”.
The main objective is to see how well eneboparatide works, and how safe it is in people with HP. In the Main Treatment period, the effects of treatment with eneboparatide will be compared to those observed in participants receiving placebo. Placebo looks like the experimental drug but does not contain active ingredient. The study will also assess how the effect of eneboparatide is maintained and how safe it is over a 52-week treatment period.
The Main Treatment period is double-blind, which means that the study team, the sponsor, and the participants will not know to which treatment the participants are assigned. Participants will be randomly assigned (by chance) to receive either eneboparatide or placebo. When participants enter the study, they must be taking calcium and vitamin D supplements. Participants will go through a screening period of up to 8 weeks. Afterwards, there is a Main Treatment period of 24 weeks, an OLE period of 28 weeks and a follow-up phone call. At the start of the treatment period calcium and vitamin D supplements will be slowly reduced and the study treatment dose will be slowly increased. Participants will receive a daily dose of the study treatment using prefilled injection pens. Injections will be taken in the abdomen, rotating the injection site. The total duration of the study participation will be up to 62 weeks.
REC name
West of Scotland REC 1
REC reference
23/WS/0071
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion