Trial Outcomes & Findings for Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes (NCT NCT04365400)
NCT ID: NCT04365400
Last Updated: 2023-06-12
Results Overview
Analysis of changes and percentage changes of triglycerides was performed using a Wilcoxon rank sum test with the Hodges Lehmann median and 95% confidence intervals estimates. For analysis of triglycerides, baseline was defined as the mean of the Baseline (Visit 3) and Screening 2/Week -1 (Visit 2) measurements.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-06-12
Participant Flow
A total of 233 patients were randomized in a 1:1:1 ratio
Participant milestones
| Measure |
DS102 2000mg
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
77
|
77
|
|
Overall Study
COMPLETED
|
49
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
30
|
27
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
DS102 2000mg
n=79 Participants
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=77 Participants
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=77 Participants
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
58.9 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
58.8 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
59.7 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
92 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
219 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Full Analysis Set (FAS): Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.
Analysis of changes and percentage changes of triglycerides was performed using a Wilcoxon rank sum test with the Hodges Lehmann median and 95% confidence intervals estimates. For analysis of triglycerides, baseline was defined as the mean of the Baseline (Visit 3) and Screening 2/Week -1 (Visit 2) measurements.
Outcome measures
| Measure |
DS102 2000mg
n=76 Participants
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=74 Participants
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=76 Participants
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 16
|
-7.886 % Change in TG
Standard Error 4.096
|
5.273 % Change in TG
Standard Error 5.361
|
-5.130 % Change in TG
Standard Error 4.945
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set (FAS): Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.
Changes from baseline of HbA1c at each visit were analysed using mixed model analysis of covariance (ANCOVA) with baseline value as a covariate.
Outcome measures
| Measure |
DS102 2000mg
n=76 Participants
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=74 Participants
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=76 Participants
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-2.255 % of HbA1c
Standard Error 1.412
|
-0.524 % of HbA1c
Standard Error 1.162
|
-0.503 % of HbA1c
Standard Error 1.446
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set (FAS): Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.
Percent change in triglycerides from baseline to weeks 4, 8, 12, 20 and 26
Outcome measures
| Measure |
DS102 2000mg
n=76 Participants
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=74 Participants
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=76 Participants
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Week 4 - Baseline
|
-9.301 % Change in TG
Standard Error 3.994
|
5.965 % Change in TG
Standard Error 9.868
|
-6.025 % Change in TG
Standard Error 4.479
|
|
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Week 8 - Baseline
|
-5.018 % Change in TG
Standard Error 3.843
|
-4.500 % Change in TG
Standard Error 4.623
|
-5.242 % Change in TG
Standard Error 4.411
|
|
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Week 12 - Baseline
|
-8.144 % Change in TG
Standard Error 4.071
|
-4.215 % Change in TG
Standard Error 6.081
|
4.022 % Change in TG
Standard Error 5.532
|
|
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Week 20 - Baseline
|
-5.666 % Change in TG
Standard Error 4.665
|
1.889 % Change in TG
Standard Error 5.005
|
-4.270 % Change in TG
Standard Error 4.494
|
|
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Week26 - Baseline
|
-8.213 % Change in TG
Standard Error 4.882
|
7.456 % Change in TG
Standard Error 6.585
|
-0.675 % Change in TG
Standard Error 5.538
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Full Analysis Set (FAS): Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.
Change in HbA1c (glycosylated haemoglobin) from baseline to weeks 4, 8, 12, 16 and 20
Outcome measures
| Measure |
DS102 2000mg
n=76 Participants
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=74 Participants
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=76 Participants
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Week 4 - Baseline
|
-2.606 % HbA1c
Standard Error 0.618
|
-1.980 % HbA1c
Standard Error 0.683
|
-1.365 % HbA1c
Standard Error 0.657
|
|
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Week 8 - Baseline
|
-3.327 % HbA1c
Standard Error 0.978
|
-2.933 % HbA1c
Standard Error 0.815
|
-2.913 % HbA1c
Standard Error 0.861
|
|
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Week 12 - Baseline
|
-3.448 % HbA1c
Standard Error 1.229
|
-2.331 % HbA1c
Standard Error 1.052
|
-1.315 % HbA1c
Standard Error 1.143
|
|
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Week 16 - Baseline
|
-2.690 % HbA1c
Standard Error 1.338
|
-1.733 % HbA1c
Standard Error 1.110
|
-1.278 % HbA1c
Standard Error 1.216
|
|
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Week 20 - Baseline
|
-4.176 % HbA1c
Standard Error 1.414
|
-0.733 % HbA1c
Standard Error 1.188
|
-0.811 % HbA1c
Standard Error 1.372
|
Adverse Events
DS102 2000mg
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
DS102 4000mg
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS102 2000mg
n=79 participants at risk
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=77 participants at risk
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=77 participants at risk
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
Other adverse events
| Measure |
DS102 2000mg
n=79 participants at risk
Participants in this group received 1000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
DS102 4000mg
n=77 participants at risk
Participants in this group received 2000mg DS102 capsules twice daily.
DS102: DS102 Epeleuton capsules
|
Placebo
n=77 participants at risk
Participants in this group received placebo capsules twice daily.
Placebo: Placebo capsules
|
|---|---|---|---|
|
Immune system disorders
Drug Hypersensitivity
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
2.5%
2/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
8/79 • Up to 28 weeks
|
16.9%
13/77 • Up to 28 weeks
|
7.8%
6/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/79 • Up to 28 weeks
|
7.8%
6/77 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
3/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/79 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Eructation
|
2.5%
2/79 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/79 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
2/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.5%
2/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Dental Caries
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Diverticulum
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Gastrointestinal disorders
Toothache
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
COVID-19
|
8.9%
7/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
6.5%
5/77 • Up to 28 weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Infections and infestations
Respiratory Tract Infection
|
1.3%
1/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.3%
1/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Conjunctivitis
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Infections and infestations
Cystitis
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Giardiasis
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Rhinitis
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
5.1%
4/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/79 • Up to 28 weeks
|
5.2%
4/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Diabetes Melitus
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Headache
|
3.8%
3/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Nervous system disorders
Dysgeusia
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Taste Disorder
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Nervous system disorders
Depressed level of Consciousness
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Nervous system disorders
Hypoesthesia
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Lacunar Stroke
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Migraine
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Sciatica
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Investigations
Blood Triglycerides Increased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Albumin Urine Present
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Blood Cholesterol Increased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
Blood Insulin Increased
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Body Temperature Increased
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
Electrocardiogram QRS Complex Abnormal
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
International Normalised Ratio Increased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Intraocular Pressure Increased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Mean Cell Haemoglobin Concentration Decreased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Mean Cell Haemoglobin Decreased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Mean Cell Volume Decreased
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
Occult Blood Positive
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Investigations
QRS Axis Abnormal
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Investigations
SARS-CoV-2 Test Positive
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
2/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
General disorders
Asthenia
|
2.5%
2/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
General disorders
Fatigue
|
1.3%
1/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
General disorders
Chest Pain
|
2.5%
2/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
General disorders
Oedema Peripheral
|
2.5%
2/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
General disorders
Pyrexia
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
General disorders
Hunger
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
General disorders
Malaise
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
General disorders
Vaccination Site Pain
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Cardiac disorders
Defect Conduction Intraventricular
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Cardiac disorders
Bundle Branch Block Right
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Cardiac disorders
Myocardial Failure
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Vascular disorders
Hypertension
|
6.3%
5/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
|
Vascular disorders
Labile Hypertension
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Microalbuminuria
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/79 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Conjunctival Abrasion
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/79 • Up to 28 weeks
|
3.9%
3/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Ear and labyrinth disorders
Ear Pain
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Immune system disorders
Immunisation Reaction
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
2.6%
2/77 • Up to 28 weeks
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/79 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Reproductive system and breast disorders
Prostatic Dysplasia
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Eye disorders
Open Angle Glaucoma
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
|
Eye disorders
Vitreous Detachment
|
1.3%
1/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/79 • Up to 28 weeks
|
0.00%
0/77 • Up to 28 weeks
|
1.3%
1/77 • Up to 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place