In hypoparathyroidism, 79% (48/61) receiving TransCon PTH versus 5% (1/21) receiving placebo met the composite primary endpoint at week 26 (p < 0.0001).
In plain wordsIn hypoparathyroidism, 79% receiving TransCon PTH versus 5% receiving placebo met the composite primary endpoint at week 26.
- Peptide
- Palopegteriparatide
- Outcome
- IncreaseComposite primary efficacy endpoint at week 26
- Study
n = 82
- Comparator
- placebo
- Analysis
- Primary
- Outcome group
- Electrolyte balance · Endocrine and hormones
- Studied dose
- initially 18 μg/d, titrated · 26 weeksAs given in this study (human).
Measurements
- participants meeting composite primary endpoint at week 26
- 79%
- TransCon PTH group, 48/61
- participants meeting composite primary endpoint at week 26
- 5%
- placebo group, 1/21
Source sentences
At week 26, 79% (48/61) of participants treated with TransCon PTH versus 5% (1/21) wiplacebo met the composite primary efficacy endpoint (p < 0.0001).
4 context sentences(design, population, supporting numbers)
The composite primary efficacy endpoint was the proportion of participants at week 26 who achieved normal albumin-adjusted serum calcium levels (8.3-10.6 mg/dL), independence from conventional therapy (requiring no active vitamin D and ≤600 mg/d of calcium), and no increase in study drug over 4 weeks before week 26.
The double-blind, placebo-controlled, 26-week, phase 3 PaTHway trial assessed the efficacy and safety of PTH replacement therapy for hypoparathyroidism individuals with the investigational drug TransCon PTH (palopegteriparatide).
Participants (n = 84) were randomized 3:1 to once-daily TransCon PTH (initially 18 μg/d) or placebo, both co-administered with conventional therapy.
The study drug and conventional therapy were titrated according to a dosing algorithm guided by serum calcium.