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Study · Randomized controlled trial · n = 82 · 2022

16 results

OR29-5 Phase 3 PaTHway Trial: Participants Treated With TransCon PTH Achieved Independence From Conventional Therapy While Maintaining Normal Serum Calcium

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Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9625133 (opens in a new tab)PepBankPUB-92878056
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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 study16

16 results from studies that gave the peptide. 16 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    At Week 26, 79% on TransCon PTH versus 5% on placebo achieved normal calcium, supplement independence, and no recent study-drug increase.

    In plain wordsAt Week 26, 79% on TransCon PTH versus 5% on placebo met requirements for calcium levels, supplement independence, and stable study-drug dosing.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseComposite primary endpoint
    Study

    n = 82

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Overall treatment effect · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    Response
    79%
    TransCon PTH, 48/61
    Response
    5%
    placebo, 1/21
    p
    < 0.0001
    comparison

    Source sentences

    Summary
    79% (48/61) of participants randomized to TransCon PTH met the composite primary efficacy endpoint, compared to 5% (1/21) in the placebo group (p <0.0001).
    2 context sentences
    Summary · context
    The composite primary efficacy endpoint was the proportion of participants at Week 26 who achieved: serum calcium levels in the normal range (8.3–10.6 mg/dL), independence from conventional therapy defined as requiring no active vitamin D and ≤600 mg/day of calcium supplementation, and no increase i…
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, TransCon PTH improved HPES physical symptom scores compared with placebo.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH improved physical symptom scores compared with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES physical symptoms
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    p
    0.0038
    physical symptoms

    Source sentences

    Summary
    TransCon PTH therapy demonstrated a significant improvement in HPES-Symptom domain scores − Physical (p = 0.0038) and Cognitive (p = 0.0055), HPES-Impact domain scores − Physical Functioning (p = 0.0046) and Daily Life (p = 0.0061), and SF-36 Physical Functioning subscale score (p = 0.0347) compared to placebo.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, TransCon PTH improved HPES cognitive symptom scores compared with placebo.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH improved cognitive symptom scores compared with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES cognitive symptoms
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    p
    0.0055
    cognitive symptoms

    Source sentences

    Summary
    TransCon PTH therapy demonstrated a significant improvement in HPES-Symptom domain scores − Physical (p = 0.0038) and Cognitive (p = 0.0055), HPES-Impact domain scores − Physical Functioning (p = 0.0046) and Daily Life (p = 0.0061), and SF-36 Physical Functioning subscale score (p = 0.0347) compared to placebo.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, TransCon PTH improved HPES physical functioning impact scores compared with placebo.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH improved physical functioning impact scores compared with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES physical functioning impact
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    p
    0.0046
    physical functioning impact

    Source sentences

    Summary
    TransCon PTH therapy demonstrated a significant improvement in HPES-Symptom domain scores − Physical (p = 0.0038) and Cognitive (p = 0.0055), HPES-Impact domain scores − Physical Functioning (p = 0.0046) and Daily Life (p = 0.0061), and SF-36 Physical Functioning subscale score (p = 0.0347) compared to placebo.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, TransCon PTH improved HPES daily life impact scores compared with placebo.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH improved daily life impact scores compared with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES daily life impact
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    p
    0.0061
    daily life impact

    Source sentences

    Summary
    TransCon PTH therapy demonstrated a significant improvement in HPES-Symptom domain scores − Physical (p = 0.0038) and Cognitive (p = 0.0055), HPES-Impact domain scores − Physical Functioning (p = 0.0046) and Daily Life (p = 0.0061), and SF-36 Physical Functioning subscale score (p = 0.0347) compared to placebo.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, TransCon PTH improved SF-36 physical functioning scores compared with placebo.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH improved SF-36 physical functioning scores compared with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedSF-36 physical functioning
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    p
    0.0347
    SF-36 physical functioning

    Source sentences

    Summary
    TransCon PTH therapy demonstrated a significant improvement in HPES-Symptom domain scores − Physical (p = 0.0038) and Cognitive (p = 0.0055), HPES-Impact domain scores − Physical Functioning (p = 0.0046) and Daily Life (p = 0.0061), and SF-36 Physical Functioning subscale score (p = 0.0347) compared to placebo.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, mean urine calcium decreased significantly from 390 to 220 mg/24-hour with TransCon PTH by Week 26, compared with 329 to 292 mg/24-hour with placebo.

    In plain wordsIn adults with hypoparathyroidism, urine calcium fell from 390 to 220 mg/24-hour with TransCon PTH and from 329 to 292 with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    DecreaseUrinary calcium change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    Urine calcium
    390 mg/24-hour
    TransCon PTH baseline
    Urine calcium
    220 mg/24-hour
    TransCon PTH Week 26
    Urine calcium
    329 mg/24-hour
    placebo baseline
    Urine calcium
    292 mg/24-hour
    placebo Week 26

    Source sentences

    Summary
    For TransCon PTH, mean urine calcium decreased significantly from 390 mg/24-hour at baseline to 220 mg/24-hour (normal range <250 mg/24-hour) at Week 26 compared to 329 mg/24-hour at baseline to 292 mg/24-hour at Week 26 for placebo.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, mean serum calcium at Week 26 was 8.9 mg/dL with TransCon PTH versus 8.2 mg/dL with placebo.

    In plain wordsIn adults with hypoparathyroidism, mean serum calcium at Week 26 was 8.9 mg/dL with TransCon PTH versus 8.2 mg/dL with placebo.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseSerum calcium at Week 26 versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    Serum calcium
    8.8 mg/dL
    TransCon PTH baseline
    Serum calcium
    8.7 mg/dL
    placebo baseline
    Serum calcium
    8.9 mg/dL
    TransCon PTH Week 26
    Serum calcium
    8.2 mg/dL
    placebo Week 26

    Source sentences

    Summary
    At baseline, mean serum calcium was 8.8 and 8.7 mg/dL for TransCon PTH and placebo respectively; 8.9 mg/dL and 8.2 mg/dL at Week 26, respectively.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  9. 09HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, 93% receiving TransCon PTH achieved independence from conventional therapy.

    In plain wordsIn adults with hypoparathyroidism, 93% receiving TransCon PTH achieved independence from conventional therapy.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableIndependence from conventional therapy
    Study

    n = 61

    Outcome group
    Supplement Requirements · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    Independence
    93%
    57/61

    Source sentences

    Summary
    93% (57/61) participants treated with TransCon PTH achieved independence from conventional therapy.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  10. 10HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, mean serum calcium was 8.8 mg/dL at baseline and 8.9 mg/dL at Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, mean serum calcium increased numerically from baseline to Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseSerum calcium
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Measurements

    Serum calcium
    8.8 mg/dL
    baseline
    Serum calcium
    8.9 mg/dL
    Week 26

    Source sentences

    Summary
    At baseline, mean serum calcium was 8.8 and 8.7 mg/dL for TransCon PTH and placebo respectively; 8.9 mg/dL and 8.2 mg/dL at Week 26, respectively.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  11. 11HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism, TransCon PTH was generally well tolerated.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH was generally well tolerated.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, TransCon PTH was well-tolerated.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  12. 12HumanNon-randomized trialSafety outcome

    In the hypoparathyroidism trial of TransCon PTH, most adverse events were mild or moderate.

    In plain wordsIn the hypoparathyroidism trial of TransCon PTH, most adverse events were mild or moderate.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The majority of adverse events (AE) were mild or moderate in severity.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  13. 13HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism, injection site reactions were among the most common study drug-related adverse events with TransCon PTH.

    In plain wordsIn adults with hypoparathyroidism, injection site reactions were among the most common drug-related adverse events with TransCon PTH.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableInjection site reactions
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The most commonly reported study drug-related AEs were injection site reactions, hypercalcemia, and headaches.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  14. 14HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism, hypercalcemia was among the most common study drug-related adverse events with TransCon PTH.

    In plain wordsIn adults with hypoparathyroidism, hypercalcemia was among the most common drug-related adverse events with TransCon PTH.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableHypercalcemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The most commonly reported study drug-related AEs were injection site reactions, hypercalcemia, and headaches.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  15. 15HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism, headaches were among the most common study drug-related adverse events with TransCon PTH.

    In plain wordsIn adults with hypoparathyroidism, headaches were among the most common drug-related adverse events with TransCon PTH.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableHeadache
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The most commonly reported study drug-related AEs were injection site reactions, hypercalcemia, and headaches.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.
  16. 16HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism receiving TransCon PTH, no study drug-related adverse event led to withdrawal.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, no drug-related adverse event led to withdrawal.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableDrug-related withdrawal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    18 mcg/d · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    No study drug-related AEs led to withdrawal from the study.
    1 context sentence
    Summary · context
    PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy.

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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