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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK093920 | U.S. NIH Grant/Contract | View source |
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The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.
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| Name | Class |
|---|---|
| New York State Psychiatric Institute | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This two-phase study aims to explore ways to predict who will respond well to the weight loss drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy. Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo followed by treatment with lorcaserin for 24 weeks (phase 2).
In phase 1, at Weeks 1 and 5, participants will take the weight loss drug lorcaserin or placebo for 7 days. At Week 5 participants will receive whichever treatment they did not receive at Week 1. At the end of Weeks 1 and 5, participants will have a lumbar puncture (spinal tap) to collect cerebrospinal fluid (CSF) for neuropeptide and hormone analyses, including proopiomelanocortin (POMC), Agouti-related protein (AgRP) and cortisol. Blood will also be obtained for neuropeptide and hormone analyses. Breakfast will be served to participants who will then complete an eating behavior profile. A laboratory test meal will be performed 4h after breakfast.
After completing both the 7 day lorcaserin and placebo studies, participants will then continue on Phase 2 of the study, which includes treatment with lorcaserin for 24 weeks. Subjects will receive nutritional counseling to reduce their daily caloric intake to 600 kcal below their calculated caloric requirement and will be encourage to exercise moderately for 30 minutes daily. Participants will visit the clinic monthly during the 24 week study period for nutritional counseling, review of food diaries, vital signs and safely labs. Blood will also be obtained for neuropeptide peptide and hormone analyses. At the end of the 24 week period subjects will come for a final study visit, including a lumbar puncture, blood sample, breakfast, an eating behavior profile and a test meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 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. |
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| Arm B | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belviq | Drug | Belviq is an oral drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo | 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. | First test meal and follow-up test meal (approximately up to 5 weeks) |
| Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations. | Baseline, up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CSF Concentrations of ß-endorphin | Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin. | Baseline, up to 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Wardlaw, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36897161 | Result | Sideri Gugger A, Dimino C, Panigrahi SK, Mayer L, Smiley RM, Korner J, Wardlaw SL. Defining Predictors of Weight Loss Response to Lorcaserin. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2262-2271. doi: 10.1210/clinem/dgad139. |
| Label | URL |
|---|---|
| NIH - lorcaserin HCl | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) - Phase 1 |
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| Washout (3 Weeks) - Phase 1 |
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| Second Intervention (7 Days) - Phase 1 |
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| Third Intervention (6 Months) - Phase 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A+B (All 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo | 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. | 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. | Posted | Mean | Standard Error | kcal | First test meal and follow-up test meal (approximately up to 5 weeks) |
|
Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LOR Time Period | Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days. Belviq: Belviq is an oral drug. |
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Study was stopped prematurely during Phase 2 due to lack of drug supply.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Wardlaw, MD | Columbia University | 212-305-3725 | sw22@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2021 | Apr 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Placebo | Drug | The placebo is made to mimic Belviq, but does not contain any active drug |
|
| Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo |
This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations. |
| Baseline, up to 5 weeks |
| Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations. | Baseline, up to 5 weeks |
| Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations. | Baseline, up to 5 weeks |
| Insulin Level | This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo. | Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo. |
| FDA approval Belviq | View source |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Lorcaserin | Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days. Belviq: Belviq is an oral drug. |
|
|
|
| Primary | Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations. | 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. | Posted | Mean | Standard Error | fmol/ml | Baseline, up to 5 weeks |
|
|
|
|
| Secondary | CSF Concentrations of ß-endorphin | Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin. | 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. | Posted | Mean | Standard Error | pg/ml | Baseline, up to 5 weeks |
|
|
|
|
| Secondary | Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations. | 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. | Posted | Mean | Standard Error | pg/ml | Baseline, up to 5 weeks |
|
|
|
| Secondary | Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations. | 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. | Posted | Mean | Standard Error | pg/ml | Baseline, up to 5 weeks |
|
|
|
| Secondary | Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo | This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations. | 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. | Posted | Mean | Standard Error | pg/ml | Baseline, up to 5 weeks |
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|
|
| Secondary | Insulin Level | This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo. | 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. | Posted | Mean | Standard Error | µIU/ml | Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo. |
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo Time Period | Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |