Trial Outcomes & Findings for MEtformin and Lorcaserin for WeighT Loss in Schizophrenia (NCT NCT02796144)
NCT ID: NCT02796144
Last Updated: 2021-03-03
Results Overview
Change in body weight in participants assigned to lorcaserin/metformin combination treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
Baseline, Last Observed Visit (Up to 52 weeks)
Results posted on
2021-03-03
Participant Flow
Participant milestones
| Measure |
Lorcaserin and Metformin
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Lorcaserin
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Lorcaserin: Max dose of 10 mg BID
|
Placebo
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
24
|
|
Overall Study
COMPLETED
|
18
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
Baseline characteristics by cohort
| Measure |
Lorcaserin and Metformin
n=23 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Lorcaserin
n=24 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Lorcaserin: Max dose of 10 mg BID
|
Placebo
n=24 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Age, Continuous
|
40.52 years
STANDARD_DEVIATION 11.45 • n=93 Participants
|
43.75 years
STANDARD_DEVIATION 10.16 • n=4 Participants
|
38.25 years
STANDARD_DEVIATION 9.87 • n=27 Participants
|
40.85 years
STANDARD_DEVIATION 10.60 • n=483 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
71 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Change in body weight in participants assigned to lorcaserin/metformin combination treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)
Outcome measures
| Measure |
Lorcaserin and Metformin
n=23 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=24 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in Body Weight in Participants Assigned to Lorcaserin/Metformin Combination Treatment and Placebo
|
-13.05 pounds
Standard Error 2.97
|
-3.02 pounds
Standard Error 2.29
|
—
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Change in body weight in participants assigned to lorcaserin monotherapy treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)
Outcome measures
| Measure |
Lorcaserin and Metformin
n=24 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=24 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in Body Weight in Participants Assigned to Lorcaserin Monotherapy Treatment and Placebo
|
-5.18 pounds
Standard Error 2.43
|
-3.02 pounds
Standard Error 2.29
|
—
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Population: The modified intent to treat (MITT) population included all randomized participants. Analyses using the MITT population were based on subjects with both baseline and post-treatment measures.
high-density lipoprotein
Outcome measures
| Measure |
Lorcaserin and Metformin
n=20 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=22 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
n=18 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in HDL Cholesterol
|
3.8 mg/dL
Standard Error 1.27
|
1.45 mg/dL
Standard Error 1.71
|
-0.78 mg/dL
Standard Error 2.63
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Population: The modified intent to treat (MITT) population included all randomized participants. Analyses using the MITT population were based on subjects with both baseline and post-treatment measures.
low-density lipoprotein
Outcome measures
| Measure |
Lorcaserin and Metformin
n=20 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=22 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
n=18 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in LDL Cholesterol
|
-7.60 mg/dL
Standard Error 3.87
|
-10.86 mg/dL
Standard Error 5.40
|
-6.83 mg/dL
Standard Error 5.03
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Population: The modified intent to treat (MITT) population included all randomized participants. Analyses using the MITT population were based on subjects with both baseline and post-treatment measures.
serum triglycerides
Outcome measures
| Measure |
Lorcaserin and Metformin
n=20 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=22 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
n=19 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in Triglycerides
|
-18.60 mg/dL
Standard Error 12.86
|
-19.68 mg/dL
Standard Error 14.97
|
-3.11 mg/dL
Standard Error 13.43
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Population: The modified intent to treat (MITT) population included all randomized participants. Analyses using the MITT population were based on subjects with both baseline and post-treatment measures.
Total Cholesterol
Outcome measures
| Measure |
Lorcaserin and Metformin
n=20 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=22 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
n=19 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in Total Cholesterol
|
-9.05 mg/dL
Standard Error 3.96
|
-13.45 mg/dL
Standard Error 7.01
|
-9.21 mg/dL
Standard Error 4.83
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Population: The modified intent to treat (MITT) population included all randomized participants. Analyses using the MITT population were based on subjects with both baseline and post-treatment measures.
glycosylated hemoglobin
Outcome measures
| Measure |
Lorcaserin and Metformin
n=20 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=23 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
n=19 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in Hemoglobin A1c
|
-0.03 percentage of glycosylated hemoglobin
Standard Error 0.05
|
0.07 percentage of glycosylated hemoglobin
Standard Error 0.08
|
0.05 percentage of glycosylated hemoglobin
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, Last Observed Visit (Up to 52 weeks)Population: The modified intent to treat (MITT) population included all randomized participants. Analyses using the MITT population were based on subjects with both baseline and post-treatment measures.
fasting blood glucose
Outcome measures
| Measure |
Lorcaserin and Metformin
n=20 Participants
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Placebo
n=22 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
Placebo
n=19 Participants
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Change in Fasting Glucose
|
-4.30 mg/dL
Standard Error 3.75
|
-3.27 mg/dL
Standard Error 2.58
|
3.53 mg/dL
Standard Error 2.11
|
Adverse Events
Lorcaserin and Metformin
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Lorcaserin
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorcaserin and Metformin
n=23 participants at risk
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Lorcaserin
n=24 participants at risk
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Lorcaserin: Max dose of 10 mg BID
|
Placebo
n=24 participants at risk
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization due to psychosis exacerbation
|
0.00%
0/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
8.3%
2/24 • Number of events 2 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
4.2%
1/24 • Number of events 2 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Gastrointestinal disorders
Hospitalization due to abdominal pain
|
0.00%
0/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
0.00%
0/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
4.2%
1/24 • Number of events 1 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Psychiatric disorders
Important Medical Intervention due to transient suicidal ideation
|
0.00%
0/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
0.00%
0/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
4.2%
1/24 • Number of events 1 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Immune system disorders
Generalized Hives and swelling
|
4.3%
1/23 • Number of events 1 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
0.00%
0/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
0.00%
0/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
Other adverse events
| Measure |
Lorcaserin and Metformin
n=23 participants at risk
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.
Lorcaserin: Max dose of 10 mg BID
Metformin: Max dose of 1,000 mg BID
|
Lorcaserin
n=24 participants at risk
Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.
Lorcaserin: Max dose of 10 mg BID
|
Placebo
n=24 participants at risk
Matching placebos will be administered for each active drug.
Placebo: Matching placebos will be administered for each drug.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
29.2%
7/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
5/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
16.7%
4/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
25.0%
6/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Gastrointestinal disorders
Diarrhea
|
34.8%
8/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
General disorders
Headache
|
47.8%
11/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
41.7%
10/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
33.3%
8/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
General disorders
Dizziness
|
34.8%
8/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
General disorders
Fatigue
|
30.4%
7/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
29.2%
7/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
54.2%
13/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
General disorders
Restlessness
|
39.1%
9/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
25.0%
6/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
16.7%
4/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching or spasms
|
26.1%
6/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
33.3%
8/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Musculoskeletal and connective tissue disorders
Muscle stiffness
|
34.8%
8/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
33.3%
8/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
33.3%
8/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Musculoskeletal and connective tissue disorders
Problems with coordination
|
21.7%
5/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
8.3%
2/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
General disorders
Excess sweating
|
21.7%
5/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
8.3%
2/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
12.5%
3/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Vascular disorders
Racing heart rate
|
21.7%
5/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
16.7%
4/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
20.8%
5/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Psychiatric disorders
Confusion
|
17.4%
4/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
4.2%
1/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
12.5%
3/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory
|
13.0%
3/23 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
8.3%
2/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
0.00%
0/24 • From the time Informed Consent was signed until the last study visit, a total duration of 52 weeks after randomization.
|
Additional Information
Lars Fredrik Jarskog, MD
University of North Carolina at Chapel Hill
Phone: 919-843-7683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place