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: 2025-03-18
Results Overview
The primary endpoint was a composite endpoint defined as the percentage of subjects 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
2025-03-18
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 |
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.
|
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 TransCon PTH
Subjects who completed the 26-week blinded period were offered open-label treatment with TransCon PTH through trial Week 182.
|
|---|---|---|---|
|
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
|
0
|
|
Open-Label Period (Weeks 26 to 182)
NOT COMPLETED
|
0
|
0
|
79
|
Reasons for withdrawal
| Measure |
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.
|
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 TransCon PTH
Subjects who completed the 26-week blinded period were offered open-label treatment with TransCon PTH through trial Week 182.
|
|---|---|---|---|
|
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)
Study Ongoing
|
0
|
0
|
79
|
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=5 Participants
|
47.3 years
STANDARD_DEVIATION 11.43 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Height
|
168.22 cm
STANDARD_DEVIATION 8.353 • n=5 Participants
|
166.67 cm
STANDARD_DEVIATION 8.831 • n=7 Participants
|
167.82 cm
STANDARD_DEVIATION 8.450 • n=5 Participants
|
|
Weight
|
77.18 kg
STANDARD_DEVIATION 17.335 • n=5 Participants
|
81.61 kg
STANDARD_DEVIATION 15.631 • n=7 Participants
|
78.31 kg
STANDARD_DEVIATION 16.932 • n=5 Participants
|
|
Body Mass Index
|
27.27 kg/m^2
STANDARD_DEVIATION 5.813 • n=5 Participants
|
29.47 kg/m^2
STANDARD_DEVIATION 5.691 • n=7 Participants
|
27.83 kg/m^2
STANDARD_DEVIATION 5.828 • n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksThe primary endpoint was a composite endpoint defined as the percentage of subjects 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
TransCon PTH
Serious events: 5 serious events
Other events: 50 other events
Deaths: 1 deaths
Placebo
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
TransCon PTH Period
Serious events: 14 serious events
Other events: 74 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
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.
|
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.
|
TransCon PTH Period
n=80 participants at risk
The total period of exposure to TransCon PTH. For subjects randomized to TransCon PTH at enrollment, this was the time from the first dose of blinded TransCon PTH until data cutoff in the open-label extension (OLE) period. The TransCon PTH Period for subjects randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until data cutoff in the OLE.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
2.5%
2/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
2.5%
2/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Skin infection
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
1.2%
1/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
Other adverse events
| Measure |
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.
|
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.
|
TransCon PTH Period
n=80 participants at risk
The total period of exposure to TransCon PTH. For subjects randomized to TransCon PTH at enrollment, this was the time from the first dose of blinded TransCon PTH until data cutoff in the open-label extension (OLE) period. The TransCon PTH Period for subjects randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until data cutoff in the OLE.
|
|---|---|---|---|
|
Investigations
Blood thyroid stimulating hormone decreased
|
3.3%
2/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
9.5%
2/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
8.8%
7/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Vascular disorders
Hypertension
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
14.3%
3/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Nervous system disorders
Headache
|
21.3%
13/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
9.5%
2/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
21.2%
17/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Nervous system disorders
Paraesthesia
|
18.0%
11/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
14.3%
3/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
22.5%
18/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Nervous system disorders
Dizziness
|
6.6%
4/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
General disorders
Injection site reaction
|
31.1%
19/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
26.2%
21/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
General disorders
Fatigue
|
14.8%
9/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
23.8%
5/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
17.5%
14/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Nausea
|
11.5%
7/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
9.5%
2/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
13.8%
11/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
6/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
8.8%
7/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Constipation
|
6.6%
4/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
4/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Psychiatric disorders
Insomnia
|
6.6%
4/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.5%
7/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
14.3%
3/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
18.8%
15/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
6/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
14.3%
3/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
15.0%
12/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.2%
5/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
42.9%
9/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
21.2%
17/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.2%
5/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
13.8%
11/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
COVID-19
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
45.0%
36/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Influenza
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Gastroenteritis viral
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Infections and infestations
Sinusitis
|
3.3%
2/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
General disorders
Asthenia
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
General disorders
Feeling abnormal
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
10.0%
8/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
2/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
2/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
4.8%
1/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Injury, poisoning and procedural complications
Medication error
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
2/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
3.3%
2/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
8.8%
7/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Cardiac disorders
Palpitations
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
7.5%
6/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
6.2%
5/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
|
Renal and urinary disorders
Pollakiuria
|
4.9%
3/61 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
0.00%
0/21 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
5.0%
4/80 • 26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place