OR21-1 The PaTH Forward Trial: Efficacy and Safety of TransCon PTH Through Week 84 for Adults With Hypoparathyroidism

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Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9625017PepBankPUB-93400793

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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-ND. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, 54 of 58 participants achieved independence from conventional therapy at Week 84.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, 93% achieved independence from conventional therapy at Week 84.
Peptide
Palopegteriparatide
Outcome
Not applicableIndependence from conventional therapy
Study
n = 58
Outcome group
Supplement Requirements · Endocrine and hormones
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Independence
93%
54/58 at Week 84
Source sentences
Summary
Fifty-four of 58 participants (93%) at Week 84 achieved independence from conventional therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079301
02HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, substudy mean serum calcium remained stable within the normal range at all sampling times.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, substudy serum calcium remained stable and normal at all sampling times.
Peptide
Palopegteriparatide
Outcome
Not applicableSubstudy serum calcium
Study
n = 12
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated
Source sentences
Summary
In the PD/PK substudy, mean sCa and uCa levels were stable in the normal range at all time points.
3 context sentences(design, population, supporting numbers)
Summary · context
After Week 58, a subset of 12 participants had frequent blood and urine sampling over 24 hours for evaluation of pharmacodynamic effect on sCa and uCa level and active PTH pharmacokinetic assessment (PD/PK substudy).
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079311
03HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, substudy mean urine calcium remained stable within the normal range at all sampling times.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, substudy urine calcium remained stable and normal at all sampling times.
Peptide
Palopegteriparatide
Outcome
Not applicableSubstudy urinary calcium
Study
n = 12
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Source sentences
Summary
In the PD/PK substudy, mean sCa and uCa levels were stable in the normal range at all time points.
3 context sentences(design, population, supporting numbers)
Summary · context
After Week 58, a subset of 12 participants had frequent blood and urine sampling over 24 hours for evaluation of pharmacodynamic effect on sCa and uCa level and active PTH pharmacokinetic assessment (PD/PK substudy).
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079312
04HumanNon-randomized trialPharmacokinetics
In adults with hypoparathyroidism receiving TransCon PTH, active PTH showed steady physiologic exposure throughout the 24-hour substudy period.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, active PTH exposure remained steady and physiologic throughout the 24-hour substudy period.
Peptide
Palopegteriparatide
Outcome
Not applicableActive PTH exposure
Study
n = 12
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated
Source sentences
Summary
Active PTH levels reflected steady physiologic exposure throughout the 24-hour period.
3 context sentences(design, population, supporting numbers)
Summary · context
After Week 58, a subset of 12 participants had frequent blood and urine sampling over 24 hours for evaluation of pharmacodynamic effect on sCa and uCa level and active PTH pharmacokinetic assessment (PD/PK substudy).
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079313
05HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium decreased from 428 mg/24-hour at baseline to 173 at Week 26.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium decreased from baseline and normalized at Week 26.
Peptide
Palopegteriparatide
Outcome
DecreaseUrinary calcium at Week 26
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Urine calcium
428 mg/24-hour
baseline
Urine calcium
173 mg/24-hour
Week 26
Source sentences
Summary
Baseline mean 24-hour uCa was above normal (428 mg/24-hour) but normalized at Week 26 (173 mg/24-hour), and sustained through Week 58 (144 mg/24-hour), and Week 84 (131 mg/24-hour).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079302
06HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium was 144 mg/24-hour at Week 58 versus 428 at baseline.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium remained normal and below baseline at Week 58.
Peptide
Palopegteriparatide
Outcome
DecreaseUrinary calcium at Week 58
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Urine calcium
428 mg/24-hour
baseline
Urine calcium
144 mg/24-hour
Week 58
Source sentences
Summary
Baseline mean 24-hour uCa was above normal (428 mg/24-hour) but normalized at Week 26 (173 mg/24-hour), and sustained through Week 58 (144 mg/24-hour), and Week 84 (131 mg/24-hour).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079303
07HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium was 131 mg/24-hour at Week 84 versus 428 at baseline.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium remained normal and below baseline at Week 84.
Peptide
Palopegteriparatide
Outcome
DecreaseUrinary calcium at Week 84
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Urine calcium
428 mg/24-hour
baseline
Urine calcium
131 mg/24-hour
Week 84
Source sentences
Summary
Baseline mean 24-hour uCa was above normal (428 mg/24-hour) but normalized at Week 26 (173 mg/24-hour), and sustained through Week 58 (144 mg/24-hour), and Week 84 (131 mg/24-hour).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079304
08HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, mean serum calcium was 8.9 mg/dL at Week 26 versus 8.8 at baseline.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, serum calcium remained normal and increased numerically at Week 26 versus baseline.
Peptide
Palopegteriparatide
Outcome
IncreaseSerum calcium at Week 26
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Serum calcium
8.8 mg/dL
baseline
Serum calcium
8.9 mg/dL
Week 26
Source sentences
Summary
Average values for sCa baseline were 8.8 mg/dL and remained in normal range at Weeks 26 (8.9 mg/dL), 58 (8.5 mg/dL) and 84 (8.5 mg/dL).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079305
09HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, mean serum calcium was 8.5 mg/dL at Week 58 versus 8.8 at baseline.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, serum calcium remained normal and decreased numerically at Week 58 versus baseline.
Peptide
Palopegteriparatide
Outcome
DecreaseSerum calcium at Week 58
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Serum calcium
8.8 mg/dL
baseline
Serum calcium
8.5 mg/dL
Week 58
Source sentences
Summary
Average values for sCa baseline were 8.8 mg/dL and remained in normal range at Weeks 26 (8.9 mg/dL), 58 (8.5 mg/dL) and 84 (8.5 mg/dL).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079306
10HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving TransCon PTH, mean serum calcium was 8.5 mg/dL at Week 84 versus 8.8 at baseline.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, serum calcium remained normal and decreased numerically at Week 84 versus baseline.
Peptide
Palopegteriparatide
Outcome
DecreaseSerum calcium at Week 84
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Measurements
Serum calcium
8.8 mg/dL
baseline
Serum calcium
8.5 mg/dL
Week 84
Source sentences
Summary
Average values for sCa baseline were 8.8 mg/dL and remained in normal range at Weeks 26 (8.9 mg/dL), 58 (8.5 mg/dL) and 84 (8.5 mg/dL).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079307
11HumanNon-randomized trialSafety outcome
In adults with hypoparathyroidism receiving TransCon PTH, most adverse events were mild and unrelated to study drug.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, most adverse events were mild and unrelated to study drug.
Peptide
Palopegteriparatide
Outcome
Not applicableAdverse event severity and relatedness
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Source sentences
Summary
The majority of adverse events (AE) were mild and unrelated to study drug; no serious AEs were reported.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079308
12HumanNon-randomized trialSafety outcome
In adults with hypoparathyroidism receiving TransCon PTH, no serious adverse events were reported.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, no serious adverse events were reported.
Peptide
Palopegteriparatide
Outcome
Not applicableSerious adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Source sentences
Summary
The majority of adverse events (AE) were mild and unrelated to study drug; no serious AEs were reported.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079309
13HumanNon-randomized trialSafety outcome
In adults with hypoparathyroidism receiving TransCon PTH, no adverse events led to drug or trial discontinuation.
In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, no adverse events led to drug or trial discontinuation.
Peptide
Palopegteriparatide
Outcome
Not applicableAdverse event discontinuations
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15, 18, or 21 mcg/d (or placebo) for 4 weeks, then titrated to maintain normocalcemiaAs given in this study (human).
Source sentences
Summary
No AEs led to discontinuation of the study drug, nor from the trial.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 2 PaTH Forward trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week clinical trial with an open-label extension (OLE) period planned through Week 214.
Summary · context
Participants received 4 weeks fixed dose of TransCon PTH (15, 18, or 21 mcg/d) or placebo co-administered with conventional therapy, followed by an OLE period during which TransCon PTH dose was titrated to maintain normocalcemia.
Report a problemFND-9340079310

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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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Abstract

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