Trial Outcomes & Findings for PTH-independent Effects of Encaleret (NCT NCT05735015)
NCT ID: NCT05735015
Last Updated: 2026-03-11
Results Overview
The percentage change in Fractional Excretion of Calcium (FECa) from baseline (24 hours before first dose of encaleret) to the last measurement while on encaleret (12 hours after last dose of encaleret). FECa is calculated using fasting blood levels and spot urine collection of calcium and creatinine. Percent change = (last measurement - baseline)/baseline x 100.
COMPLETED
PHASE2
13 participants
Last measurement (12 hours after last dose of encaleret), baseline (24 hours before first dose of encaleret)
2026-03-11
Participant Flow
Of the 13 participants consented, three participants were screen failures.
Participant milestones
| Measure |
Participants With Permanent Hypoparathyroidism
Participants with permanent post-surgical hypoparathyroidism (\>1 year after surgery) received encaleret 162 mg orally twice daily for up to five days.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Encaleret for 2 Days
|
3
|
|
Overall Study
Encaleret for 5 Days
|
7
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PTH-independent Effects of Encaleret
Baseline characteristics by cohort
| Measure |
Participants With Permanent Hypoparathyroidism
n=10 Participants
Participants with permanent post-surgical hypoparathyroidism (\>1 year after surgery) received encaleret 162 mg orally twice daily for up to five days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Last measurement (12 hours after last dose of encaleret), baseline (24 hours before first dose of encaleret)Population: Modified intent to treat population
The percentage change in Fractional Excretion of Calcium (FECa) from baseline (24 hours before first dose of encaleret) to the last measurement while on encaleret (12 hours after last dose of encaleret). FECa is calculated using fasting blood levels and spot urine collection of calcium and creatinine. Percent change = (last measurement - baseline)/baseline x 100.
Outcome measures
| Measure |
Participants With Permanent Hypoparathyroidism
n=10 Participants
Participants with permanent post-surgical hypoparathyroidism (\>1 year after surgery) received encaleret 162 mg orally twice daily for up to five days.
|
|---|---|
|
Percent Change in Fractional Excretion of Calcium (FECa)
|
-39 percentage of change
Standard Deviation 29
|
SECONDARY outcome
Timeframe: Day 1-5 while on treatmentPopulation: Modified intent to treat population
Proportion of participants who achieve a concomitant normal or elevated fasting blood calcium (albumin-corrected calcium\>8.5 mg/dL) and a normal 24-hour urinary calcium level (\<250 mg/24 hours for women, \<300 mg/24 hours for men) on encaleret at any point between day 1 and day 5 while on treatment.
Outcome measures
| Measure |
Participants With Permanent Hypoparathyroidism
n=10 Participants
Participants with permanent post-surgical hypoparathyroidism (\>1 year after surgery) received encaleret 162 mg orally twice daily for up to five days.
|
|---|---|
|
Proportion of Participants With Concomitant Normal Blood and Urine Calcium
|
0.9 Proportion of participants
Interval 0.55 to 1.0
|
Adverse Events
Participants With Permanent Hypoparathyroidism
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Permanent Hypoparathyroidism
n=10 participants at risk
Participants with permanent post-surgical hypoparathyroidism (\>1 year after surgery) received encaleret 162 mg orally twice daily for up to five days.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Eye disorders
Conjunctivitis
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Gastrointestinal disorders
Inguinal hernia
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • 30 days after last dose of drug intervention
|
|
General disorders
Fatigue
|
20.0%
2/10 • 30 days after last dose of drug intervention
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
80.0%
8/10 • 30 days after last dose of drug intervention
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder polyp
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • 30 days after last dose of drug intervention
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Skin and subcutaneous tissue disorders
Impetigo
|
10.0%
1/10 • 30 days after last dose of drug intervention
|
|
Vascular disorders
Thrombophlebitis superficial
|
20.0%
2/10 • 30 days after last dose of drug intervention
|
Additional Information
Dr. Iris Hartley
National Institute of Dental and Craniofacial Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place