Trial Outcomes & Findings for A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers (NCT NCT05206370)
NCT ID: NCT05206370
Last Updated: 2026-01-14
Results Overview
Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤ 10 parts per million (ppm).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
792 participants
Primary outcome timeframe
Weeks 3 to 6
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
Placebo + Behavioral Support
One placebo tablet orally (PO) three times daily (TID) for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
12-Week Cytisinicline + Behavioral Support
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
|
|---|---|---|---|
|
Overall Study
STARTED
|
265
|
263
|
264
|
|
Overall Study
COMPLETED
|
209
|
207
|
212
|
|
Overall Study
NOT COMPLETED
|
56
|
56
|
52
|
Reasons for withdrawal
| Measure |
Placebo + Behavioral Support
One placebo tablet orally (PO) three times daily (TID) for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
12-Week Cytisinicline + Behavioral Support
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
27
|
30
|
24
|
|
Overall Study
Physician Decision
|
1
|
3
|
2
|
|
Overall Study
Death
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
23
|
16
|
14
|
|
Overall Study
Other, Nor Specified
|
2
|
2
|
4
|
Baseline Characteristics
A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
Baseline characteristics by cohort
| Measure |
Placebo + Behavioral Support
n=265 Participants
One placebo tablet PO TID for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=263 Participants
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
12-Week Cytisinicline + Behavioral Support
n=264 Participants
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
|
Total
n=792 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11.4 • n=14 Participants
|
52 years
STANDARD_DEVIATION 11.7 • n=10 Participants
|
52 years
STANDARD_DEVIATION 12.3 • n=24 Participants
|
52 years
STANDARD_DEVIATION 11.8 • n=78 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=14 Participants
|
142 Participants
n=10 Participants
|
151 Participants
n=24 Participants
|
439 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=14 Participants
|
121 Participants
n=10 Participants
|
113 Participants
n=24 Participants
|
353 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=14 Participants
|
15 Participants
n=10 Participants
|
13 Participants
n=24 Participants
|
45 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
248 Participants
n=14 Participants
|
248 Participants
n=10 Participants
|
251 Participants
n=24 Participants
|
747 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=14 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
51 Participants
n=14 Participants
|
38 Participants
n=10 Participants
|
50 Participants
n=24 Participants
|
139 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
White
|
210 Participants
n=14 Participants
|
216 Participants
n=10 Participants
|
205 Participants
n=24 Participants
|
631 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
3 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Weeks 3 to 6Population: All Randomized Set: all randomized participants. Placebo and 6-week treatment arms only.
Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤ 10 parts per million (ppm).
Outcome measures
| Measure |
Placebo + Behavioral Support
n=265 Participants
One placebo tablet PO TID for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=263 Participants
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
|---|---|---|
|
Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6
|
6.0 percentage of participants
|
14.8 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 9 to 12Population: All Randomized Set: all randomized participants, Placebo and 12-week treatment arms only.
Smoking abstinence as verified by weekly expired CO measurements ≤ 10 ppm.
Outcome measures
| Measure |
Placebo + Behavioral Support
n=265 Participants
One placebo tablet PO TID for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=264 Participants
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
|---|---|---|
|
Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12
|
9.4 percentage of participants
|
30.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 3 to Week 24Population: All Randomized Set: all randomized participants, Placebo and 6-week treatment arms only.
Smoking abstinence as verified by expired CO measurements ≤ 10 ppm. Measurements were weekly from Week 3 to Week 12 and monthly from Week 12 to Week 24.
Outcome measures
| Measure |
Placebo + Behavioral Support
n=265 Participants
One placebo tablet PO TID for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=263 Participants
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 3 to Week 24
|
1.1 percentage of participants
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 9 to Week 24Population: All Randomized Set: all randomized participants, Placebo and 12-week treatment arms only.
Smoking abstinence as verified by expired CO measurements ≤ 10 ppm. Measurements were weekly from Week 9 to Week 12 and monthly from Week 12 to Week 24.
Outcome measures
| Measure |
Placebo + Behavioral Support
n=265 Participants
One placebo tablet PO TID for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=264 Participants
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 9 to Week 24
|
4.2 percentage of participants
|
20.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All Randomized Set: All randomized participants. Participants in the cytisinicline arms.
Relapse is defined as participant reported resuming smoking or an expired CO measure ≥ 10 ppm. Relapse is defined as a participant having met one of the following: not being abstinent from Weeks 3 to 6; not being abstinent at the Week 12 visit; not being abstinent or not self-reporting abstinence during the Week 16 to Week 24 follow-up period. (During the follow-up period \[Weeks 16 to 24\], up to a total of 5 cigarettes could have been smoked.)
Outcome measures
| Measure |
Placebo + Behavioral Support
n=263 Participants
One placebo tablet PO TID for 12 weeks plus behavioral support
|
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=264 Participants
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
|---|---|---|
|
Percentage of Participants Taking Cytisinicline Who Are Relapse-Free at Week 24
|
8.7 percentage of participants
|
10.6 percentage of participants
|
Adverse Events
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
Serious events: 8 serious events
Other events: 132 other events
Deaths: 1 deaths
12-Week Cytisinicline + Behavioral Support
Serious events: 8 serious events
Other events: 137 other events
Deaths: 3 deaths
Placebo + Behavioral Support
Serious events: 8 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=263 participants at risk
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
12-Week Cytisinicline + Behavioral Support
n=260 participants at risk
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
|
Placebo + Behavioral Support
n=262 participants at risk
one placebo tablet PO TID for 12 weeks plus behavioral support
|
|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Sepsis
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
General disorders
Fatigue
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
General disorders
Hernia
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Groin abscess
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Nervous system disorders
Migraine with aura
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Nervous system disorders
Transient ischaemic attack
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Psychiatric disorders
Suicide attempt
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.38%
1/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.00%
0/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
Other adverse events
| Measure |
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
n=263 participants at risk
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
|
12-Week Cytisinicline + Behavioral Support
n=260 participants at risk
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
|
Placebo + Behavioral Support
n=262 participants at risk
one placebo tablet PO TID for 12 weeks plus behavioral support
|
|---|---|---|---|
|
Psychiatric disorders
Irritability
|
1.5%
4/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.1%
3/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
9/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
3.1%
8/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.3%
6/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.77%
2/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Bronchitis
|
0.76%
2/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.77%
2/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.7%
7/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
COVID-19
|
6.8%
18/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
10.4%
27/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
10.3%
27/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Nervous system disorders
Headache
|
8.0%
21/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
8.5%
22/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
6.9%
18/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.7%
7/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.1%
3/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Psychiatric disorders
Abnormal dreams
|
9.1%
24/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
7.7%
20/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
6.1%
16/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Nasopharyngitis
|
0.76%
2/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.2%
3/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.7%
7/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Sinusitis
|
2.3%
6/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.9%
5/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
11/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
4.6%
12/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
3.4%
9/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Psychiatric disorders
Anxiety
|
3.0%
8/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.76%
2/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.38%
1/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Psychiatric disorders
Depression
|
2.3%
6/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.9%
5/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.3%
6/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.77%
2/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.1%
3/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Psychiatric disorders
Insomnia
|
11.0%
29/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
12.3%
32/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
7.6%
20/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
10/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.5%
4/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.76%
2/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
3/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.76%
2/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Nervous system disorders
Dizziness
|
1.1%
3/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
3.8%
10/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.76%
2/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
General disorders
Fatigue
|
2.7%
7/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
4.2%
11/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.1%
3/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Constipation
|
2.7%
7/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.1%
3/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
12/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
3.1%
8/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
4.6%
12/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Dry mouth
|
4.6%
12/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
6/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.9%
5/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
0.76%
2/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Nausea
|
9.9%
26/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
7.3%
19/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
7.3%
19/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
2/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
1.2%
3/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
2.3%
6/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
|
Vascular disorders
Hypertension
|
2.7%
7/263 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
3.1%
8/260 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
5.0%
13/262 • From signing of informed consent through Week 24
Safety Set: participants who received study drug
|
Additional Information
Roxann Becco, Sr. Director, Clinical Operations
Achieve Life Sciences
Phone: 425-686-1500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
- Publication restrictions are in place
Restriction type: OTHER