Trial Outcomes & Findings for A Study in Participants With Non-cirrhotic NASH With Fibrosis (NCT NCT05638737)

NCT ID: NCT05638737

Last Updated: 2025-07-09

Results Overview

ALT at 12 weeks relative to baseline. ALT is measured in Units per litre (U/L)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 112 participants
• Primary outcome timeframe: Measurements on Baseline, Week 2, Week 4, Week 8, Week 12 and Week 16. Change reported from Baseline to Week 12.
• Results posted on: 2025-07-09

Participant Flow

Participant milestones

Measure	Placebo Once-daily dosing of Placebo for 12 weeks	Treatment Once-daily dosing of 5mg mitiperstat for 12 weeks
Overall Study STARTED	56	56
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	Placebo Once-daily dosing of Placebo for 12 weeks	Treatment Once-daily dosing of 5mg mitiperstat for 12 weeks
Overall Study Withdrawal by Subject	4	7

Baseline Characteristics

A Study in Participants With Non-cirrhotic NASH With Fibrosis

Baseline characteristics by cohort

Measure	Treatment n=56 Participants Once-daily dosing of 5mg mitiperstat for 12 weeks	Placebo n=56 Participants Once-daily dosing of Placebo for 12 weeks	Total n=112 Participants Total of all reporting groups
Age, Continuous	52 Years STANDARD_DEVIATION 13.1 • n=5 Participants	53.7 Years STANDARD_DEVIATION 9.7 • n=7 Participants	52.8 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Race/Ethnicity, Customized HISPANIC OR LATINO	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized NOT HISPANIC OR LATINO	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized MULTIPLE	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized NOT REPORTED	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized OTHER	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measurements on Baseline, Week 2, Week 4, Week 8, Week 12 and Week 16. Change reported from Baseline to Week 12.

ALT at 12 weeks relative to baseline. ALT is measured in Units per litre (U/L)

Outcome measures

Measure	Mitiperstat (5mg) n=56 Participants Once-daily dosing of 5mg mitiperstat for 12 weeks	Placebo n=56 Participants Once-daily dosing of Placebo for 12 weeks
Relative to Baseline Alanine Aminotransferase (ALT)	0.959 Ratio Interval 0.885 to 1.04	0.895 Ratio Interval 0.824 to 0.972

SECONDARY outcome

Timeframe: Measurements on Baseline, Week 4 and Week 12

Pro-C3 at 12 weeks relative to baseline. Pro-C3 is measured in nanograms per milliliter (ng/mL).

Outcome measures

Measure	Mitiperstat (5mg) n=56 Participants Once-daily dosing of 5mg mitiperstat for 12 weeks	Placebo n=56 Participants Once-daily dosing of Placebo for 12 weeks
Relative to Baseline Pro-C3	1.009 Ratio Interval 0.96 to 1.06	1.018 Ratio Interval 0.971 to 1.068

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=56 participants at risk Once-daily dosing of 5mg mitiperstat for 12 weeks	Placebo n=56 participants at risk Once-daily dosing of Placebo for 12 weeks
Infections and infestations Bronchitis	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Herpes zoster	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Pneumonia	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Sepsis	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.

Other adverse events

Measure	Treatment n=56 participants at risk Once-daily dosing of 5mg mitiperstat for 12 weeks	Placebo n=56 participants at risk Once-daily dosing of Placebo for 12 weeks
Gastrointestinal disorders Constipation	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Dry mouth	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Dyspepsia	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Faeces hard	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Food poisoning	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Haemorrhoids	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Nausea	3.6% 2/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Blood and lymphatic system disorders Leukopenia	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Toothache	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Vomiting	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
General disorders Illness	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
General disorders Influenza like illness	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
General disorders Non-cardiac chest pain	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
General disorders Oedema peripheral	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
General disorders Pyrexia	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Hepatobiliary disorders Hepatitis alcoholic	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Immune system disorders Allergy to arthropod bite	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Immune system disorders Food allergy	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Abscess	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Covid-19	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Gastroenteritis viral	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Hordeolum	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Influenza	5.4% 3/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Nasopharyngitis	5.4% 3/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Oral herpes	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Otitis externa	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Cardiac disorders Tachycardia	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Soft tissue infection	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Tonsillitis	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Tooth abscess	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Tooth infection	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Upper respiratory tract infection	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Infections and infestations Urinary tract infection	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	5.4% 3/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Injury, poisoning and procedural complications Burns second degree	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Endocrine disorders Thyroid mass	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Injury, poisoning and procedural complications Limb injury	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Injury, poisoning and procedural complications Sunburn	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Alanine aminotransferase increased	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Aspartate aminotransferase increased	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Blood creatine phosphokinase increased	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Blood pressure increased	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Hepatic enzyme increased	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Investigations Transaminases increased	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Abdominal discomfort	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Metabolism and nutrition disorders Dehydration	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Metabolism and nutrition disorders Hypovitaminosis	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Metabolism and nutrition disorders Metabolic acidosis	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Musculoskeletal and connective tissue disorders Flank pain	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Abdominal pain	1.8% 1/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Nervous system disorders Dizziness	5.4% 3/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Nervous system disorders Headache	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Nervous system disorders Radiculopathy	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Psychiatric disorders Anxiety	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Psychiatric disorders Insomnia	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Renal and urinary disorders Haematuria	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Renal and urinary disorders Polyuria	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Renal and urinary disorders Renal failure	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Dermatitis contact	1.8% 1/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Hidradenitis	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Pruritus	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	7.1% 4/56 • Number of events 5 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Rash	3.6% 2/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.4% 3/56 • Number of events 3 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	3.6% 2/56 • Number of events 2 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Gastrointestinal disorders Anal pruritus	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Skin reaction	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Vascular disorders Hypertension	0.00% 0/56 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.
Vascular disorders Orthostatic hypotension	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.	1.8% 1/56 • Number of events 1 • Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60