Pharmacodynamics of sustained levels of PTH following palopegteriparatide treatment in adults with hypoparathyroidism.

Khan AA, Rejnmark L, Jain R, Pihl S, Breinholt VM, Zhao C, Lai B, Ukena J, Sibley CT, Shu AD

Journal of the Endocrine Society18 Apr 2026Cited by 1 (Europe PMC)

PMID42440695PMCIDPMC13334101DOI10.1210/jendso/bvag098PepBankPUB-42440695

Summary

PurposePalopegteriparatide is a prodrug of parathyroid hormone (PTH) (1-34), administered once daily. It is designed to provide active PTH within the physiologic range for 24 hours/day. The effects of palopegteriparatide on serum and urine markers were explored to determine if the pharmacodynamic profile of palopegteriparatide reflects continuous disease control in adults with hypoparathyroidism.MethodsA 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide. Plasma PTH, serum calcium (albumin-adjusted), and serum phosphate concentrations were evaluated at 4-hour intervals. Urinary calcium, phosphate, and citrate concentrations were determined from each of six 4-hour collection periods. Descriptive statistics were performed.ResultsPalopegteriparatide doses ranged from 12 to 33 µg/day and resulted in continuous exposure to active PTH within the estimated normal range over 24 hours. Mean serum calcium and serum phosphate were maintained near or within the normal ranges. Median urine calcium concentration was stable in the normal range for all 4-hour collection periods. Urine phosphate concentrations showed minor variability across collection intervals, and urine citrate was maintained above the lower limit of normal.ConclusionPalopegteriparatide provided continuous exposure to active PTH within the physiological range. The expected pharmacodynamic effects of continuous PTH exposure on serum and urine chemistries were consistent with the efficacy and safety of palopegteriparatide demonstrated in the published PaTH Forward and PaTHway clinical trials.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialPharmacokinetics
In adults with hypoparathyroidism, palopegteriparatide maintained active PTH exposure within the estimated normal range over 24 hours.
In plain wordsIn adults with hypoparathyroidism, palopegteriparatide maintained active PTH within the estimated normal range over 24 hours.
Peptide
Palopegteriparatide
Outcome
Not applicableActive PTH exposure
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
12 to 33 µg/dayAs given in this study (human).
Source sentences
Summary
Palopegteriparatide doses ranged from 12 to 33 µg/day and resulted in continuous exposure to active PTH within the estimated normal range over 24 hours.
1 context sentence(design, population, supporting numbers)
Summary · context
A 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide.
Show in the study text Report a problemFND-4244069501
02HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, serum calcium remained near or within normal ranges during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, serum calcium remained near or within normal ranges during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableSerum calcium
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
12 to 33 µg/dayAs given in this study (human).
Source sentences
Summary
Mean serum calcium and serum phosphate were maintained near or within the normal ranges.
1 context sentence(design, population, supporting numbers)
Summary · context
A 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide.
Show in the study text Report a problemFND-4244069502
03HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, serum phosphate remained near or within normal ranges during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, serum phosphate remained near or within normal ranges during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableSerum phosphate
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
12 to 33 µg/dayAs given in this study (human).
Source sentences
Summary
Mean serum calcium and serum phosphate were maintained near or within the normal ranges.
1 context sentence(design, population, supporting numbers)
Summary · context
A 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide.
Show in the study text Report a problemFND-4244069503
04HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, median urine calcium remained stable within the normal range across all 4-hour collections during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, urine calcium remained stable within the normal range during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableUrine calcium concentration
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
12 to 33 µg/dayAs given in this study (human).
Source sentences
Summary
Median urine calcium concentration was stable in the normal range for all 4-hour collection periods.
1 context sentence(design, population, supporting numbers)
Summary · context
A 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide.
Show in the study text Report a problemFND-4244069504
05HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, urine phosphate showed minor variability across collection intervals during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, urine phosphate showed minor variability across collection intervals during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableUrine phosphate concentration variability
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
12 to 33 µg/dayAs given in this study (human).
Source sentences
Summary
Urine phosphate concentrations showed minor variability across collection intervals, and urine citrate was maintained above the lower limit of normal.
1 context sentence(design, population, supporting numbers)
Summary · context
A 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide.
Show in the study text Report a problemFND-4244069505
06HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, urine citrate remained above the lower normal limit during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, urine citrate remained above the lower normal limit during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableUrine citrate concentration
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
12 to 33 µg/dayAs given in this study (human).
Source sentences
Summary
Urine phosphate concentrations showed minor variability across collection intervals, and urine citrate was maintained above the lower limit of normal.
1 context sentence(design, population, supporting numbers)
Summary · context
A 24-hour sub-study was conducted during the PaTH Forward trial. Eligible participants were those who completed the Week 58 visit and received stable doses of palopegteriparatide for the prior week. Upon admission to the clinical research unit, participants received their usual dose of palopegteriparatide.
Show in the study text Report a problemFND-4244069506

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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