Trial Outcomes & Findings for A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation (NCT NCT02044874)
NCT ID: NCT02044874
Last Updated: 2019-04-16
Results Overview
Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
603 participants
Primary outcome timeframe
Week 9 - Week 12
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
APD356 10 mg b.i.d.
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
APD356-lorcaserin hydrochloride
|
Placebo 10 mg b.i.d
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
201
|
202
|
200
|
|
Overall Study
COMPLETED
|
171
|
147
|
140
|
|
Overall Study
NOT COMPLETED
|
30
|
55
|
60
|
Reasons for withdrawal
| Measure |
APD356 10 mg b.i.d.
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
APD356-lorcaserin hydrochloride
|
Placebo 10 mg b.i.d
Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
16
|
23
|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
27
|
21
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
1
|
|
Overall Study
Other
|
7
|
3
|
8
|
Baseline Characteristics
A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
Baseline characteristics by cohort
| Measure |
APD356 10 mg b.i.d.
n=201 Participants
APD356-lorcaserin hydrochloride 10 mg twice daily
|
APD356 10 mg q.d.
n=202 Participants
APD356-lorcaserin hydrochloride 10 mg once daily
|
Placebo 10 mg b.i.d
n=200 Participants
Placebo 10 mg twice daily
|
Total
n=603 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
|
200 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
598 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
328 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
275 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
201 participants
n=5 Participants
|
202 participants
n=7 Participants
|
200 participants
n=5 Participants
|
603 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 9 - Week 12Population: Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement
Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm.
Outcome measures
| Measure |
APD356 10 mg b.i.d.
n=196 Participants
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
n=195 Participants
APD356-lorcaserin hydrochloride
|
Placebo
n=195 Participants
Placebo
|
|---|---|---|---|
|
Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12
|
15.31 percentage of participants
|
8.72 percentage of participants
|
5.64 percentage of participants
|
SECONDARY outcome
Timeframe: Week 3 to Week 12Population: Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement
The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm
Outcome measures
| Measure |
APD356 10 mg b.i.d.
n=196 Participants
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
n=195 Participants
APD356-lorcaserin hydrochloride
|
Placebo
n=195 Participants
Placebo
|
|---|---|---|---|
|
Abstinence During Weeks 3-12
|
5.61 percentage of participants
|
3.59 percentage of participants
|
2.05 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement
The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm
Outcome measures
| Measure |
APD356 10 mg b.i.d.
n=196 Participants
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
n=195 Participants
APD356-lorcaserin hydrochloride
|
Placebo
n=195 Participants
Placebo
|
|---|---|---|---|
|
The 7 Day Point Prevalence or Weekly Abstinence at Week 8
|
16.33 percentage of participants
|
9.74 percentage of participants
|
9.23 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement
The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm
Outcome measures
| Measure |
APD356 10 mg b.i.d.
n=196 Participants
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
n=195 Participants
APD356-lorcaserin hydrochloride
|
Placebo
n=195 Participants
Placebo
|
|---|---|---|---|
|
The 7 Day Point Prevalence or Weekly Abstinence at Week 12
|
20.41 percentage of paticipants
|
13.85 percentage of paticipants
|
11.79 percentage of paticipants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement
Change in body weight from Week 1 (baseline) to Week 12
Outcome measures
| Measure |
APD356 10 mg b.i.d.
n=170 Participants
APD356-lorcaserin hydrochloride
|
APD356 10 mg q.d.
n=150 Participants
APD356-lorcaserin hydrochloride
|
Placebo
n=141 Participants
Placebo
|
|---|---|---|---|
|
Body Weight
|
-0.98 Kg
Interval -1.35 to -0.61
|
-0.35 Kg
Interval -0.74 to 0.04
|
-0.01 Kg
Interval -0.4 to 0.38
|
Adverse Events
APD356 10 mg b.i.d.
Serious events: 3 serious events
Other events: 70 other events
Deaths: 0 deaths
APD356 10 mg q.d.
Serious events: 4 serious events
Other events: 65 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APD356 10 mg b.i.d.
n=201 participants at risk
APD356-lorcaserin hydrochloride 10 mg twice daily
|
APD356 10 mg q.d.
n=202 participants at risk
APD356-lorcaserin hydrochloride 10 mg once daily
|
Placebo
n=200 participants at risk
Placebo
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/200 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Cardiac disorders
Palpitations
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
General disorders
Chest pain
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Investigations
Blood carbon monoxide increased
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/201 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.50%
1/202 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/201 • Number of events 1 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/202 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
0.00%
0/200 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
Other adverse events
| Measure |
APD356 10 mg b.i.d.
n=201 participants at risk
APD356-lorcaserin hydrochloride 10 mg twice daily
|
APD356 10 mg q.d.
n=202 participants at risk
APD356-lorcaserin hydrochloride 10 mg once daily
|
Placebo
n=200 participants at risk
Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.0%
16/201 • Number of events 16 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
4.5%
9/202 • Number of events 9 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
5.0%
10/200 • Number of events 10 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
12/201 • Number of events 12 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
6.4%
13/202 • Number of events 13 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
3.5%
7/200 • Number of events 7 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
10/201 • Number of events 10 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
3.5%
7/202 • Number of events 7 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
3.0%
6/200 • Number of events 6 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
General disorders
Fatigue
|
5.5%
11/201 • Number of events 11 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
3.0%
6/202 • Number of events 6 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
2.0%
4/200 • Number of events 4 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
12/201 • Number of events 12 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
4.0%
8/202 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
6.5%
13/200 • Number of events 13 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
8/201 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
3.0%
6/202 • Number of events 6 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
4.0%
8/200 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Nervous system disorders
Headache
|
9.5%
19/201 • Number of events 19 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
11.4%
23/202 • Number of events 23 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
8.0%
16/200 • Number of events 16 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Nervous system disorders
Dizziness
|
4.5%
9/201 • Number of events 9 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
5.4%
11/202 • Number of events 11 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
2.0%
4/200 • Number of events 4 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Psychiatric disorders
Abnormal dreams
|
4.0%
8/201 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
4.0%
8/202 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
2.0%
4/200 • Number of events 4 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Psychiatric disorders
Anxiety
|
2.0%
4/201 • Number of events 4 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
2.5%
5/202 • Number of events 5 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
4.0%
8/200 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Psychiatric disorders
Insomnia
|
3.0%
6/201 • Number of events 6 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
1.5%
3/202 • Number of events 3 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
2.5%
5/200 • Number of events 5 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
|
Psychiatric disorders
Irritability
|
1.00%
2/201 • Number of events 2 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
1.5%
3/202 • Number of events 3 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
4.0%
8/200 • Number of events 8 • Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60