Trial Outcomes & Findings for A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects (NCT NCT04480710)

NCT ID: NCT04480710

Last Updated: 2022-07-15

Results Overview

Number of adverse events, serious adverse events, and clinical laboratory abnormalities.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Time from informed consent to study day 42.

Results posted on

2022-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo, 75mg Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 75mg CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 225mg CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule	CRV431 225mg CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule
Overall Study STARTED	6	15	9	17
Overall Study COMPLETED	6	12	8	17
Overall Study NOT COMPLETED	0	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CRV431 75mg CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 225mg CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Missing baseline value

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRV431 75mg n=15 Participants CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 75mg n=6 Participants Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 225mg n=17 Participants CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule	Placebo, 225mg n=9 Participants CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule	Total n=47 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 9.9 • n=15 Participants	61.8 years STANDARD_DEVIATION 8.7 • n=6 Participants	54 years STANDARD_DEVIATION 13.3 • n=17 Participants	61.1 years STANDARD_DEVIATION 13.8 • n=9 Participants	58.0 years STANDARD_DEVIATION 11.94 • n=47 Participants
Sex: Female, Male Female	8 Participants n=15 Participants	3 Participants n=6 Participants	10 Participants n=17 Participants	2 Participants n=9 Participants	23 Participants n=47 Participants
Sex: Female, Male Male	7 Participants n=15 Participants	3 Participants n=6 Participants	7 Participants n=17 Participants	7 Participants n=9 Participants	24 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=15 Participants	3 Participants n=6 Participants	10 Participants n=17 Participants	6 Participants n=9 Participants	25 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=15 Participants	3 Participants n=6 Participants	7 Participants n=17 Participants	3 Participants n=9 Participants	22 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	0 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	0 Participants n=47 Participants
Race (NIH/OMB) White	14 Participants n=15 Participants	5 Participants n=6 Participants	17 Participants n=17 Participants	9 Participants n=9 Participants	45 Participants n=47 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=15 Participants	1 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=9 Participants	2 Participants n=47 Participants
BMI	37.1 kg/m^2 STANDARD_DEVIATION 8.5 • n=15 Participants	36.1 kg/m^2 STANDARD_DEVIATION 6.5 • n=6 Participants	37.7 kg/m^2 STANDARD_DEVIATION 6.4 • n=17 Participants	39.2 kg/m^2 STANDARD_DEVIATION 10.6 • n=9 Participants	37.57 kg/m^2 STANDARD_DEVIATION 7.82 • n=47 Participants
ALT	62.5 IU/mL STANDARD_DEVIATION 42.1 • n=15 Participants	75.8 IU/mL STANDARD_DEVIATION 36.8 • n=6 Participants	39.3 IU/mL STANDARD_DEVIATION 18.4 • n=17 Participants	52.9 IU/mL STANDARD_DEVIATION 35.6 • n=9 Participants	51.46 IU/mL STANDARD_DEVIATION 32.18 • n=47 Participants
AST	51.9 IU/mL STANDARD_DEVIATION 35.3 • n=15 Participants	70.2 IU/mL STANDARD_DEVIATION 40.1 • n=6 Participants	33.1 IU/mL STANDARD_DEVIATION 14.3 • n=17 Participants	44.7 IU/mL STANDARD_DEVIATION 36 • n=9 Participants	43.83 IU/mL STANDARD_DEVIATION 27.71 • n=47 Participants
Pro-C3	23.15 ng/mL STANDARD_DEVIATION 6.88 • n=15 Participants • Missing baseline value	23.19 ng/mL STANDARD_DEVIATION 10.55 • n=5 Participants • Missing baseline value	19.94 ng/mL STANDARD_DEVIATION 9.07 • n=14 Participants • Missing baseline value	18.56 ng/mL STANDARD_DEVIATION 5.84 • n=8 Participants • Missing baseline value	22.70 ng/mL STANDARD_DEVIATION 12.44 • n=42 Participants • Missing baseline value
ELF Score	10.3 units on a scale STANDARD_DEVIATION 0.8 • n=15 Participants	10.1 units on a scale STANDARD_DEVIATION 0.4 • n=6 Participants	9.8 units on a scale STANDARD_DEVIATION 0.9 • n=17 Participants	9.7 units on a scale STANDARD_DEVIATION 1.0 • n=9 Participants	10.0 units on a scale STANDARD_DEVIATION 0.74 • n=47 Participants

PRIMARY outcome

Timeframe: Time from informed consent to study day 42.

Population: Safety population.

Number of adverse events, serious adverse events, and clinical laboratory abnormalities.

Outcome measures

Outcome measures
Measure	Placebo, 75mg n=6 Participants Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 75mg n=15 Participants CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 225mg n=9 Participants CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule	CRV431 225mg n=17 Participants CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Number of Treatment Emergent Adverse Events leading to study withdrawl	0 Number of treatment emergent AE	1 Number of treatment emergent AE	0 Number of treatment emergent AE	0 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Number of Treatment Emergent Adverse Events	4 Number of treatment emergent AE	8 Number of treatment emergent AE	3 Number of treatment emergent AE	21 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Relationship-unrelated	4 Number of treatment emergent AE	6 Number of treatment emergent AE	2 Number of treatment emergent AE	13 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Relationship-possibly related	0 Number of treatment emergent AE	0 Number of treatment emergent AE	1 Number of treatment emergent AE	1 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Relationship-probably related	0 Number of treatment emergent AE	2 Number of treatment emergent AE	0 Number of treatment emergent AE	7 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Severity-Mild Grade 1	4 Number of treatment emergent AE	3 Number of treatment emergent AE	2 Number of treatment emergent AE	16 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Severity-Moderate Grade2	0 Number of treatment emergent AE	5 Number of treatment emergent AE	1 Number of treatment emergent AE	4 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Severity-Severe Grade 3	0 Number of treatment emergent AE	0 Number of treatment emergent AE	0 Number of treatment emergent AE	1 Number of treatment emergent AE
Number of Safety and Tolerability Events of CRV431 Versus Placebo. Severity-Grade 4	0 Number of treatment emergent AE	0 Number of treatment emergent AE	0 Number of treatment emergent AE	0 Number of treatment emergent AE

PRIMARY outcome

Timeframe: Day 1 and Day 28

The Tmax value is defined as time to reach maximum whole blood concentration. Each value is a median for the cohort along with the standard deviation presented in hours for Day 1 and Day 28.

Outcome measures

Outcome measures
Measure	Placebo, 75mg n=15 Participants Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 75mg n=15 Participants CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 225mg n=17 Participants CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule	CRV431 225mg n=17 Participants CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule
Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.	4.41 hours Standard Deviation 1.6	4 hours Standard Deviation 2.05	2.59 hours Standard Deviation 1.54	2 hours Standard Deviation 0.73

PRIMARY outcome

Timeframe: Day 1 and Day 28

The Cmax value is defined as the maximum whole blood concentration presented as ng/mL. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28.

Outcome measures

Outcome measures
Measure	Placebo, 75mg n=15 Participants Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 75mg n=17 Participants CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 225mg n=15 Participants CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule	CRV431 225mg n=17 Participants CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule
Cmax, of Once Daily (QD) 75mg and 22mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.	347.24 ng/mL Standard Deviation 168.26	1147.31 ng/mL Standard Deviation 389.09	1218.88 ng/mL Standard Deviation 302.25	1876.9 ng/mL Standard Deviation 118.19

PRIMARY outcome

Timeframe: Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28.

The AUC 0-last value is defined as the area under the whole blood concentration time curve from time 0 to the time of the last measurable concentration. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28.

Outcome measures

Outcome measures
Measure	Placebo, 75mg n=15 Participants Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 75mg n=15 Participants CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 225mg n=17 Participants CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule	CRV431 225mg n=17 Participants CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule
AUC 0-last, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 in Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.	2251.32 h*ng/mL Standard Deviation 1054.20	8851.96 h*ng/mL Standard Deviation 2132.29	6348.85 h*ng/mL Standard Deviation 2819.58	13784.34 h*ng/mL Standard Deviation 4656.34

Adverse Events

CRV431 75mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo, 75mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CRV431 225mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo, 225mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operations

Hepion Pharmaceuticals Inc

Phone: 732-902-4016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CRV431 75mg n=15 participants at risk CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule	Placebo, 75mg n=6 participants at risk Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule	CRV431 225mg n=17 participants at risk CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule	Placebo, 225mg n=9 participants at risk CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule
Gastrointestinal disorders Abdominal Distension	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	11.1% 1/9 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.
Nervous system disorders Dizziness	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	16.7% 1/6 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Renal and urinary disorders Dysuria	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
General disorders Gastroesophageal reflux disease	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Cardiac disorders Palpitations	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	11.8% 2/17 • Number of events 2 • Adverse events were collected from time of informed consent to day 42 of the study.	11.1% 1/9 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	11.8% 2/17 • Number of events 2 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	16.7% 1/6 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	11.1% 1/9 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.
General disorders Oedema peripheral	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	16.7% 1/6 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Nervous system disorders Headache	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	16.7% 1/6 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Gastrointestinal disorders Nausea	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
General disorders Fatigue	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
General disorders Pain	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	11.1% 1/9 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.
General disorders Pyrexia	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Immune system disorders Seasonal Allergy	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Infections and infestations Urinary tract infection	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Investigations Blood pressure increased	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Investigations Body temperature decreased	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Investigations SARS-CoV2 test positive	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Investigations Weight increased	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Nervous system disorders Migraine	6.7% 1/15 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/17 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/15 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/6 • Adverse events were collected from time of informed consent to day 42 of the study.	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent to day 42 of the study.	0.00% 0/9 • Adverse events were collected from time of informed consent to day 42 of the study.