Trial Outcomes & Findings for Lorcaserin for Preventing Weight Gain Among Smokers (NCT NCT02393547)

NCT ID: NCT02393547

Last Updated: 2017-06-06

Results Overview

change in weight from baseline to week 12

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-06-06

Participant Flow

Subjects were recruited from the community surrounding Mayo Clinic (Rochester, MN) between September 2013 and July 2014. Overweight or obese daily smokers who were interested in stopping cigarette use were recruited through the news media and local advertisements in Rochester, MN.

The current study included an initial telephone screen.After the initial screen, eligible subjects were invited to come for potential enrollment. Visits prior accrual (drug dispensing) included an information meeting (screening, physician physical exam, and informed consent) and baseline visit (screening, baseline measures and drug dispensing).

Participant milestones

Measure	Varenicline + Lorcaserin Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Overall Study STARTED	20
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Varenicline + Lorcaserin Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Lorcaserin for Preventing Weight Gain Among Smokers

Baseline characteristics by cohort

Measure	Varenicline + Lorcaserin n=20 Participants Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.7 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Weight	90.3 kg STANDARD_DEVIATION 26.2 • n=5 Participants
Body Mass Index	30.4 units on a scale -- kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants
Waist Circumference	102.1 cm STANDARD_DEVIATION 16.0 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: subjects (n=10) who met criteria for prolonged smoking abstinence at week 12

change in weight from baseline to week 12

Outcome measures

Measure	Varenicline + Lorcaserin n=10 Participants Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Post Cessation Weight Change	1.1 kg Standard Deviation 3.9

SECONDARY outcome

Timeframe: 12 Weeks

Population: subjects (n=10) who met criteria for prolonged smoking abstinence at week 12

Change in waist circumference from baseline to week 12

Outcome measures

Measure	Varenicline + Lorcaserin n=10 Participants Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Waist Circumference	0.2 cm Standard Deviation 6.0

SECONDARY outcome

Timeframe: 12 weeks

prolonged smoking abstinence at week 12

Outcome measures

Measure	Varenicline + Lorcaserin n=20 Participants Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Smoking Abstinence Rates	10 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: subjects (N=10) who met criteria for prolonged smoking abstinence at week 12

Change in BMI from baseline to week 12

Outcome measures

Measure	Varenicline + Lorcaserin n=10 Participants Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
BMI	0.3 kg/m^2 Standard Deviation 1.3

Adverse Events

Varenicline + Lorcaserin

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Varenicline + Lorcaserin n=20 participants at risk Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Psychiatric disorders Suicidal Ideation	5.0% 1/20 • Number of events 1 • 12 weeks

Other adverse events

Measure	Varenicline + Lorcaserin n=20 participants at risk Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
General disorders sleep disturbance	20.0% 4/20 • Number of events 5 • 12 weeks
Gastrointestinal disorders constipation	10.0% 2/20 • Number of events 3 • 12 weeks
Gastrointestinal disorders heart burn	5.0% 1/20 • Number of events 1 • 12 weeks
General disorders nausea	15.0% 3/20 • Number of events 3 • 12 weeks
Nervous system disorders headaches	5.0% 1/20 • Number of events 1 • 12 weeks
General disorders dry mouth	5.0% 1/20 • Number of events 1 • 12 weeks

Additional Information

Ryan T. Hurt, MD

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place