A Phase 4 interventional study of Belviq and Placebo in Overweight and Obesity, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Columbia University · Phase 4, Interventional, and Other
Among 20 studies testing lorcaserin in Obesity — none open to participants now, 1 under way, none of them phase 3. lorcaserin · Obesity.
Among the 20 studies testing lorcaserin in Obesity, this one is the 16th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 4, and was the 19th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →None of the 20 studies testing lorcaserin in Obesity is open now.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 4 · Phase 3 6 · Phase 4 6
First in 2004; this study’s year is marked. 1 started in 2018.
This study's enrollment of 32 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 92 across the 20 interventional studies. Of the 19 that completed or were terminated, 12 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 20 have an industry lead sponsor. The 7 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
41 studies in Obesity by Columbia University: 10 open now, 11 under way, none of them phase 3. Of 29 finished, 8 (28%) have results posted.
Among the 41 studies in Obesity by Columbia University, this one is the 15th largest by enrollment of the 33 interventional ones that give a count, is the only one that started in 2018, is one of 4 in phase 4, and was the 20th registered.
Columbia University’s Obesity studies by the year they started, since 2002.
1 of the studies testing lorcaserin in Obesity that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02400359Beth Israel Deaconess Medical CenterLorcaserin in Obesity: Identification of CNS Targets Using fMRI | 2027-06 |
Among the 20 studies testing lorcaserin in Obesity, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Columbia University’s 41 in Obesity:
This tab as a report to print or save as PDF → With an account.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 32 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Belviq · Drug: Placebo
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.
Drug: Belviq · Drug: Placebo
Belviq is an oral drug
Also known as: Lorcaserin
The placebo is made to mimic Belviq, but does not contain any active drug
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.
Time frame: 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.
Time frame: Baseline, up to 5 weeks
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.
Time frame: Baseline, up to 5 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo.
| Milestone | Arm A (LOR-Placebo-LOR) | Arm B (Placebo-LOR-LOR) |
|---|---|---|
| Started | 14 | 16 |
| Completed | 14 | 16 |
| Not completed | 0 | 0 |
| Milestone | Arm A (LOR-Placebo-LOR) | Arm B (Placebo-LOR-LOR) |
|---|---|---|
| Started | 14 | 16 |
| Completed | 14 | 16 |
| Not completed | 0 | 0 |
| Milestone | Arm A (LOR-Placebo-LOR) | Arm B (Placebo-LOR-LOR) |
|---|---|---|
| Started | 14 | 16 |
| Completed | 14 | 16 |
| Not completed | 0 | 0 |
| Milestone | Arm A (LOR-Placebo-LOR) | Arm B (Placebo-LOR-LOR) |
|---|---|---|
| Started | 14 | 16 |
| Completed | 10 | 9 |
| Not completed | 4 | 7 |
| Withdrew: Study was stopped due to unavailable study drug supply | 4 | 7 |
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.
| kcal | Placebo | Lorcaserin |
|---|---|---|
| Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo | 919.8 ± 118.7 | 891.9 ± 109.0 |
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.
| fmol/ml | Placebo | Lorcaserin |
|---|---|---|
| Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo | 256.9 ± 18.5 | 225.0 ± 15.9 |
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.
| pg/ml | Placebo | Lorcaserin |
|---|---|---|
| CSF Concentrations of ß-endorphin | 49.07 ± 2.6 | 55.8 ± 3.2 |
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.
| pg/ml | Placebo | Lorcaserin |
|---|---|---|
| Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo | 25.9 ± 3.0 | 24.2 ± 3.1 |
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.
| pg/ml | Placebo | Lorcaserin |
|---|---|---|
| Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo | 78.7 ± 7.7 | 79.2 ± 7.9 |
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.
| pg/ml | Placebo | Lorcaserin |
|---|---|---|
| Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo | 5.7 ± 0.22 | 6.08 ± 0.33 |
This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo.
| µIU/ml | Placebo | Lorcaserin |
|---|---|---|
| Insulin Level | 20.1 ± 3.27 | 13.2 ± 1.16 |
Collected over Up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LOR Time Period | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Placebo Time Period | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Arm A+B (All Participants) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 32 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Arm A+B (All Participants) |
|---|---|
| Female | 28 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Arm A+B (All Participants) |
|---|---|
| Hispanic or Latino | 12 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Arm A+B (All Participants) |
|---|---|
| United States | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Feb 2020, 25 months.
Results were first posted in Sep 2021, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lorcaserin