Trial Outcomes & Findings for A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism (NCT NCT04701203)
NCT ID: NCT04701203
Last Updated: 2026-02-09
Results Overview
The primary endpoint was a multi-component endpoint that included the percentage of participants who met the following criteria at 26 weeks of blinded treatment: 1) albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and 2) independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and 3) independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks), and 4) no increase in prescribed study drug within 4 weeks prior to Week 26 visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
26 weeks
Results posted on
2026-02-09
Participant Flow
Overall, 84 subjects were randomized and 82 subjects were dosed. Enrollment of subjects occurred in seven countries: Canada, Denmark, Germany, Italy, Hungary, Norway, and the United States.
A total of 106 subjects were screened and 84 of these met eligibility criteria and were enrolled into the study. Two subjects randomized to TransCon PTH were not treated (1 subject was diagnosed with a recurrence of cancer, and 1 subject withdrew consent). A total of 82 subjects were therefore included in the Intent-to-Treat (ITT) and the Safety analysis populations.
Participant milestones
| Measure |
Double Blind: TransCon PTH
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Double Blind: Placebo
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Open-Label Extension Period: TransCon PTH
Participants who completed the 26-week double-blind treatment period, continued into the open-label extension period and received treatment with TransCon PTH up to Week 182. All participants received individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day).
|
|---|---|---|---|
|
Blinded Period (Weeks 0 to 26)
STARTED
|
61
|
21
|
0
|
|
Blinded Period (Weeks 0 to 26)
COMPLETED
|
60
|
19
|
0
|
|
Blinded Period (Weeks 0 to 26)
NOT COMPLETED
|
1
|
2
|
0
|
|
Open-Label Period (Weeks 26 to 182)
STARTED
|
0
|
0
|
79
|
|
Open-Label Period (Weeks 26 to 182)
COMPLETED
|
0
|
0
|
73
|
|
Open-Label Period (Weeks 26 to 182)
NOT COMPLETED
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
Double Blind: TransCon PTH
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Double Blind: Placebo
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Open-Label Extension Period: TransCon PTH
Participants who completed the 26-week double-blind treatment period, continued into the open-label extension period and received treatment with TransCon PTH up to Week 182. All participants received individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day).
|
|---|---|---|---|
|
Blinded Period (Weeks 0 to 26)
Death
|
1
|
0
|
0
|
|
Blinded Period (Weeks 0 to 26)
Withdrawal by Subject
|
0
|
1
|
0
|
|
Blinded Period (Weeks 0 to 26)
Adverse Event
|
0
|
1
|
0
|
|
Open-Label Period (Weeks 26 to 182)
Withdrawal by Subject
|
0
|
0
|
5
|
|
Open-Label Period (Weeks 26 to 182)
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
Baseline characteristics by cohort
| Measure |
TransCon PTH
n=61 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=21 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 13.13 • n=41 Participants
|
47.3 years
STANDARD_DEVIATION 11.43 • n=1581 Participants
|
48.6 years
STANDARD_DEVIATION 12.67 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
64 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
76 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
57 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
75 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Height
|
168.22 cm
STANDARD_DEVIATION 8.353 • n=41 Participants
|
166.67 cm
STANDARD_DEVIATION 8.831 • n=1581 Participants
|
167.82 cm
STANDARD_DEVIATION 8.450 • n=4626 Participants
|
|
Weight
|
77.18 kg
STANDARD_DEVIATION 17.335 • n=41 Participants
|
81.61 kg
STANDARD_DEVIATION 15.631 • n=1581 Participants
|
78.31 kg
STANDARD_DEVIATION 16.932 • n=4626 Participants
|
|
Body Mass Index
|
27.27 kg/m^2
STANDARD_DEVIATION 5.813 • n=41 Participants
|
29.47 kg/m^2
STANDARD_DEVIATION 5.691 • n=1581 Participants
|
27.83 kg/m^2
STANDARD_DEVIATION 5.828 • n=4626 Participants
|
PRIMARY outcome
Timeframe: 26 weeksThe primary endpoint was a multi-component endpoint that included the percentage of participants who met the following criteria at 26 weeks of blinded treatment: 1) albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and 2) independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and 3) independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks), and 4) no increase in prescribed study drug within 4 weeks prior to Week 26 visit.
Outcome measures
| Measure |
TransCon PTH
n=61 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=21 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
|---|---|---|
|
Efficacy - Primary Endpoint During the Blinded Period
|
78.7 Percentage of participants
Interval 66.3 to 88.1
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.
Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Physical Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related physical symptoms.
Outcome measures
| Measure |
TransCon PTH
n=59 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=19 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
|---|---|---|
|
Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score
|
-21.01 units on a scale
Interval -25.41 to -16.6
|
-4.81 units on a scale
Interval -15.22 to 5.59
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.
Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Cognitive Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related cognitive symptoms.
Outcome measures
| Measure |
TransCon PTH
n=59 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=19 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
|---|---|---|
|
Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score
|
-20.49 units on a scale
Interval -25.67 to -15.31
|
-6.16 units on a scale
Interval -15.92 to 3.6
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.
Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Physical Functioning Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in physical functioning health-related quality of life.
Outcome measures
| Measure |
TransCon PTH
n=59 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=19 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
|---|---|---|
|
Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score
|
-18.29 units on a scale
Interval -23.59 to -12.99
|
-1.01 units on a scale
Interval -12.4 to 10.38
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.
Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Daily Life Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in daily health-related quality of life.
Outcome measures
| Measure |
TransCon PTH
n=59 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=19 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
|---|---|---|
|
Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score
|
-17.65 units on a scale
Interval -22.39 to -12.91
|
-0.36 units on a scale
Interval -12.19 to 11.46
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.
Change from baseline in the 36-item Short Form Survey (SF-36) Physical Functioning subscale score, a generic health survey, at 26 weeks of treatment. The Physical Functioning subscale uses a range of 19-57.6 and values represent the change in scores from baseline. An increase in SF-36 score denotes an improvement in physical functioning health-related quality of life.
Outcome measures
| Measure |
TransCon PTH
n=59 Participants
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Placebo
n=19 Participants
Placebo for TransCon PTH delivered once daily by subcutaneous injection
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
|---|---|---|
|
Change From Baseline to Week 26 in SF-36 Physical Functioning Subscale Score
|
5.29 units on a scale
Interval 3.47 to 7.1
|
0.12 units on a scale
Interval -4.64 to 4.89
|
Adverse Events
Double Blind: TransCon PTH
Serious events: 5 serious events
Other events: 50 other events
Deaths: 1 deaths
Double Blind: Placebo
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Total TransCon PTH Period
Serious events: 20 serious events
Other events: 72 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Double Blind: TransCon PTH
n=61 participants at risk
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose during the blinded period
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Double Blind: Placebo
n=21 participants at risk
Placebo for TransCon PTH delivered once daily by subcutaneous injection during the blinded period
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Total TransCon PTH Period
n=80 participants at risk
Participants who completed the 26-week double blind treatment period in placebo and TransCon PTH groups, continued into the open-label extension period and received treatment with TransCon PTH up to Week 182. This period refers to total period of exposure to TransCon PTH. For participants randomized to TransCon PTH at enrollment, the "TransCon PTH Period" was the time from first dose of blinded TransCon PTH until final analysis in OLE period. The TransCon PTH Period for participants randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until final analysis in the OLE period.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
2.5%
2/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
2.5%
2/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
2.5%
2/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Skin infection
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.2%
1/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
Other adverse events
| Measure |
Double Blind: TransCon PTH
n=61 participants at risk
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose during the blinded period
TransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Double Blind: Placebo
n=21 participants at risk
Placebo for TransCon PTH delivered once daily by subcutaneous injection during the blinded period
Placebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
|
Total TransCon PTH Period
n=80 participants at risk
Participants who completed the 26-week double blind treatment period in placebo and TransCon PTH groups, continued into the open-label extension period and received treatment with TransCon PTH up to Week 182. This period refers to total period of exposure to TransCon PTH. For participants randomized to TransCon PTH at enrollment, the "TransCon PTH Period" was the time from first dose of blinded TransCon PTH until final analysis in OLE period. The TransCon PTH Period for participants randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until final analysis in the OLE period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.5%
7/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
9.5%
2/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
15.0%
12/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
6/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Constipation
|
6.6%
4/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
4/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Psychiatric disorders
Insomnia
|
6.6%
4/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.5%
7/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
14.3%
3/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
21.2%
17/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
6/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
9.5%
2/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
16.2%
13/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.2%
5/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
42.9%
9/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
18.8%
15/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.2%
5/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
11.2%
9/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
COVID-19
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
50.0%
40/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Influenza
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.0%
8/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Gastroenteritis viral
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Sinusitis
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Asthenia
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
7.5%
6/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.0%
8/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.0%
8/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Medication error
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Cardiac disorders
Palpitations
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
11.2%
9/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
12.5%
10/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
7.5%
6/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Ear infection
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Brain fog
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
7.5%
6/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Dizziness postural
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
2/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.2%
5/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
4.8%
1/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.0%
4/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Dizziness
|
6.6%
4/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.8%
7/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Injection site reaction
|
31.1%
19/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
25.0%
20/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Fatigue
|
14.8%
9/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
23.8%
5/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
22.5%
18/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
14.3%
3/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
13.8%
11/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Vascular disorders
Hypertension
|
4.9%
3/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
14.3%
3/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
15.0%
12/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Headache
|
21.3%
13/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
9.5%
2/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
23.8%
19/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Paraesthesia
|
19.7%
12/61 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
14.3%
3/21 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
26.2%
21/80 • From Week 0 to Week 26 for double-blind treatment period and up to Week 182 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place