Study · Non-randomized trial · n = 82 · 2024

8 results

Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial.

Rejnmark L, Gosmanova EO, Khan AA, Makita N, Imanishi Y, Takeuchi Y, Sprague S, Shoback DM, Kohlmeier L, Rubin MR, Palermo A, Schwarz P and 9 more

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Gagnon C, Tsourdi E, Zhao C, Makara MA, Ominsky MS, Lai B, Ukena J, Sibley CT, Shu AD

Advances in therapy30 Apr 2024Cited by 33 (Europe PMC)

PMID38691316PMCIDPMC11133178DOI10.1007/s12325-024-02843-8PepBankPUB-38691316

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialOther
In adults with hypoparathyroidism, over 95% (78/82) remained enrolled in the palopegteriparatide open-label extension at week 52.
In plain wordsIn adults with hypoparathyroidism, over 95% remained enrolled in the palopegteriparatide extension at week 52.
Peptide
Palopegteriparatide
Outcome
Not applicableTrial retention at week 52
Study
n = 82
Outcome group
Treatment adherence and retention · Endocrine and hormones
Studied dose
Dose not stated
Measurements
participants remaining enrolled in OLE
> 95%
in the phase 3 PaTHway open-label extension, week 52; 78/82 participants
participants remaining enrolled in OLE
78 participants
in the phase 3 PaTHway open-label extension, week 52; of 82
Source sentences
Summary
At week 52, over 95% (78/82) of participants remained enrolled in the OLE
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131601
02HumanNon-randomized trialEfficacy outcome
Among adults remaining in the palopegteriparatide extension at week 52, 86% maintained normocalcemia.
In plain wordsAmong adults remaining in the palopegteriparatide extension at week 52, 86% maintained normal calcium.
Peptide
Palopegteriparatide
Outcome
Not applicableNormocalcemia at week 52
Study
n = 78
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated
Measurements
participants maintaining normocalcemia
86%
in the phase 3 PaTHway open-label extension, week 52; among those remaining in OLE
Source sentences
Summary
At week 52, over 95% (78/82) of participants remained enrolled in the OLE and of those, 86% maintained normocalcemia and 95% achieved independence from conventional therapy (no active vitamin D and ≤ 600 mg/day of calcium), with none requiring active vitamin D.
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131602
03HumanNon-randomized trialEfficacy outcome
Among adults remaining in the palopegteriparatide extension at week 52, 95% achieved independence from conventional therapy.
In plain wordsAmong adults remaining in the palopegteriparatide extension at week 52, 95% no longer required conventional therapy as defined in the study.
Peptide
Palopegteriparatide
Outcome
Not applicableIndependence from conventional therapy at week 52
Study
n = 78
Outcome group
Conventional therapy requirements · Endocrine and hormones
Studied dose
Dose not stated
Measurements
participants achieving independence from conventional therapy
95%
in the phase 3 PaTHway open-label extension, week 52; among those remaining in OLE
Source sentences
Summary
At week 52, over 95% (78/82) of participants remained enrolled in the OLE and of those, 86% maintained normocalcemia and 95% achieved independence from conventional therapy (no active vitamin D and ≤ 600 mg/day of calcium), with none requiring active vitamin D.
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131603
04HumanNon-randomized trialEfficacy outcome
Among adults remaining in the palopegteriparatide extension at week 52, none required active vitamin D.
In plain wordsAmong adults remaining in the palopegteriparatide extension at week 52, none required active vitamin D.
Peptide
Palopegteriparatide
Outcome
Not applicableActive vitamin D requirement at week 52
Study
n = 78
Outcome group
Conventional therapy requirements · Endocrine and hormones
Studied dose
Dose not stated
Source sentences
Summary
At week 52, over 95% (78/82) of participants remained enrolled in the OLE and of those, 86% maintained normocalcemia and 95% achieved independence from conventional therapy (no active vitamin D and ≤ 600 mg/day of calcium), with none requiring active vitamin D.
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131604
05HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, palopegteriparatide was associated with mean eGFR increase of 9.3 (SD 11.7) mL/min/1.73 m² over 52 weeks (P < 0.0001).
In plain wordsIn adults with hypoparathyroidism, eGFR increased from baseline during 52 weeks of palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR change over 52 weeks
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
mean eGFR change from baseline
9.3 mL/min/1.73 m2
52 weeks, all participants
SD of eGFR change
11.7 mL/min/1.73 m2
52 weeks, all participants
Source sentences
Summary
Treatment with palopegteriparatide over 52 weeks resulted in a mean (SD) increase in eGFR of 9.3 (11.7) mL/min/1.73 m² from baseline (P 2.
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131605
06HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving palopegteriparatide over 52 weeks, 43% had an eGFR increase ≥ 10 mL/min/1.73 m².
In plain wordsIn adults with hypoparathyroidism receiving palopegteriparatide over 52 weeks, 43% had an eGFR increase of at least 10 mL/min/1.73 m².
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR increase threshold
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
participants with eGFR increase of at least 10 mL/min/1.73 m2
43%
52 weeks, all participants
Source sentences
Summary
Treatment with palopegteriparatide over 52 weeks resulted in a mean (SD) increase in eGFR of 9.3 (11.7) mL/min/1.73 m² from baseline (P 2.
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131606
07HumanNon-randomized trialEfficacy outcome
With baseline eGFR < 60, adults receiving palopegteriparatide for 52 weeks had mean eGFR increase 11.5 (SD 11.3) mL/min/1.73 m² (P < 0.001).
In plain wordsIn adults with baseline eGFR below 60, eGFR increased from baseline after 52 weeks of palopegteriparatide.
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR change with baseline eGFR below 60
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
mean eGFR change from baseline
11.5 mL/min/1.73 m2
52 weeks, baseline eGFR < 60
SD of eGFR change
11.3 mL/min/1.73 m2
52 weeks, baseline eGFR < 60
Source sentences
Summary
In participants with baseline eGFR 2, 52 weeks of treatment with palopegteriparatide resulted in a mean (SD) increase of 11.5 (11.3) mL/min/1.73 m² (P < 0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131607
08HumanNon-randomized trialSafety outcome
In adults with hypoparathyroidism, no nephrolithiasis was reported with palopegteriparatide through week 52.
In plain wordsIn adults with hypoparathyroidism, no kidney stones were reported with palopegteriparatide through week 52.
Peptide
Palopegteriparatide
Outcome
Not applicableNephrolithiasis through week 52
Study
n: not reported in source
Outcome group
Adverse events · Kidney and urinary
Studied dose
Dose not stated
Source sentences
Summary
One case of nephrolithiasis was reported for a participant in the placebo group during blinded treatment; none were reported through week 52 with palopegteriparatide.
3 context sentences(design, population, supporting numbers)
Summary · context
PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period.
Summary · context
Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR).
Summary · context
A subgroup analysis was performed with participants stratified by baseline eGFR 2.
Report a problemFND-3869131608

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

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT07299838

Palopegteriparatide in Chronic Hypoparathyroidism

National and Kapodistrian University of Athensn = 901 Jun 2024 to 23 Oct 2025

Hypoparathyroidism

Trial page ClinicalTrials.govUpdated 26 Jan 2026

CompletedPhase 3Results postedNCT04701203

A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism

Ascendis Pharma Bone Diseases A/Sn = 8416 Feb 2021 to 21 Jan 2025

Hypoparathyroidism · Endocrine System Diseases · Parathyroid Diseases

Trial page ClinicalTrials.govUpdated 7 Jul 2026

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

Subjects

Terms as the source lists them.

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