Trial Outcomes & Findings for Predictors of Lorcaserin-Induced Weight Loss (NCT NCT03353220)

Results Overview

This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

First test meal and follow-up test meal (approximately up to 5 weeks)

Results posted on

2024-03-27

Participant Flow

Out of the 32 enrolled subjects: 30 subjects completed Phase 1 (Arms A and B) and 30 subjects continued into Phase 2. However, the study was stopped prematurely during Phase 2 as lorcaserin was withdrawn from the market. Data was collected and analyzed for the 30 subjects that completed phase 1 out of 32 subjects; the 2 subjects who did not complete phase 1 were excluded from analysis. 19 subjects completed phase 2.

Participant milestones

Participant milestones
Measure	Arm A (LOR-Placebo-LOR) Phase 1: Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days. Phase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks. Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.	Arm B (Placebo-LOR-LOR) Phase 1: Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days. Phase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks. Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.
First Intervention (7 Days) - Phase 1 STARTED	14	16
First Intervention (7 Days) - Phase 1 COMPLETED	14	16
First Intervention (7 Days) - Phase 1 NOT COMPLETED	0	0
Washout (3 Weeks) - Phase 1 STARTED	14	16
Washout (3 Weeks) - Phase 1 COMPLETED	14	16
Washout (3 Weeks) - Phase 1 NOT COMPLETED	0	0
Second Intervention (7 Days) - Phase 1 STARTED	14	16
Second Intervention (7 Days) - Phase 1 COMPLETED	14	16
Second Intervention (7 Days) - Phase 1 NOT COMPLETED	0	0
Third Intervention (6 Months) - Phase 2 STARTED	14	16
Third Intervention (6 Months) - Phase 2 COMPLETED	10	9
Third Intervention (6 Months) - Phase 2 NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (LOR-Placebo-LOR) Phase 1: Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days. Phase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks. Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.	Arm B (Placebo-LOR-LOR) Phase 1: Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days. Phase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks. Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.
Third Intervention (6 Months) - Phase 2 Study was stopped due to unavailable study drug supply	4	7

Baseline Characteristics

Predictors of Lorcaserin-Induced Weight Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A+B (All Participants) n=32 Participants Phase 1: Participants either receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period then cross over to receive placebo twice a day for 7 days (Arm A) OR receive placebo twice a day for 7 days followed by a 3 week washout period then cross over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days (Arm B). Phase 2: Participants (from both arms) will receive additional lorcaserin (Belviq) for 24 weeks. Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug. Belviq: Belviq is an oral drug Placebo: The placebo is made to mimic Belviq, but does not contain any active drug
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: First test meal and follow-up test meal (approximately up to 5 weeks)

Population: The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.

This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.