Trial Outcomes & Findings for A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease (NCT NCT03019536)
NCT ID: NCT03019536
Last Updated: 2023-10-10
Results Overview
A summary of other non-serious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Baseline up to Week 65
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Placebo IV
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
9
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
7
|
9
|
|
Overall Study
COMPLETED
|
5
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo IV
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo IV
n=6 Participants
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to g further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
n=7 Participants
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to g further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
n=9 Participants
210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to g further doses), followed by a 16-week follow-up period.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 65Population: All randomized participants who received at least one dose of study drug.
A summary of other non-serious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo IV
n=6 Participants
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
n=7 Participants
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
n=9 Participants
210 mg LY3303560 administered IV every 4 weeks with the option of continuing treatment up to 49 weeks, followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 49 (Pre-dose, 0.5, 2, 4, 8, 336, 672, 1344, 2016, 2688 hours post-dose)Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK Cmax at Week 49
Outcome measures
| Measure |
Placebo IV
n=6 Participants
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
n=8 Participants
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
210 mg LY3303560 administered IV every 4 weeks with the option of continuing treatment up to 49 weeks, followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3303560 at Week 49
|
29.2 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 23
|
83.9 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: Week 49 (Pre-dose, 0.5, 2, 4, 8, 336, 672, 1344, 2016, 2688 hours post-dose)Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC 0-tau at Week 49.
Outcome measures
| Measure |
Placebo IV
n=5 Participants
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
n=8 Participants
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
210 mg LY3303560 administered IV every 4 weeks with the option of continuing treatment up to 49 weeks, followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Serum Concentration Time Curve During the Dosing Interval (AUC 0-tau) of LY3303560
|
9140 microgram*hour per milliliter (µg*hr/mL)
Geometric Coefficient of Variation 21
|
24200 microgram*hour per milliliter (µg*hr/mL)
Geometric Coefficient of Variation 19
|
—
|
Adverse Events
Placebo IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
70 mg LY3303560
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
210 mg LY3303560
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo IV
n=6 participants at risk
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
n=7 participants at risk
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
n=9 participants at risk
210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo IV
n=6 participants at risk
Placebo administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
70 mg LY3303560
n=7 participants at risk
70 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
210 mg LY3303560
n=9 participants at risk
210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up 6 further doses), followed by a 16-week follow-up period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 8 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Number of events 3 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Culture urine positive
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Urogram
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebellar microhaemorrhage
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Nightmare
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Social circumstances
Alcohol use
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Poor venous access
|
0.00%
0/6 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2 • Baseline up to Week 65
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60