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The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise |
|
| Control Group | Active Comparator | Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine-Topiramate | Drug | Extended Release at dose of 7.5/46 mg oral daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Body Weight | Percent change in body weight | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders | Percentage of participants who loss 5% or more of total body weight | baseline to 12 weeks |
| Percentage of Responders | Percentage of participants with at least 10% total body weight loss |
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Inclusion criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andres J Acosta | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33759389 | Derived | Acosta A, Camilleri M, Abu Dayyeh B, Calderon G, Gonzalez D, McRae A, Rossini W, Singh S, Burton D, Clark MM. Selection of Antiobesity Medications Based on Phenotypes Enhances Weight Loss: A Pragmatic Trial in an Obesity Clinic. Obesity (Silver Spring). 2021 Apr;29(4):662-671. doi: 10.1002/oby.23120. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) |
| FG001 | Control Group | Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) Phentermine: 15-37.5 mg oral daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Total Body Weight | Percent change in body weight | Posted | Median | Inter-Quartile Range | percent change | baseline to 12 weeks |
|
Baseline to 12 months
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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 | Intervention Group | Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| During study | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andres Acosta | Mayo Clinic | 507-266-6931 | acosta.andres@mayo.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 | May 18, 2020 | Jun 26, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576188 | Qsymia |
| D000069450 | Liraglutide |
| D009271 | Naltrexone |
| D016642 | Bupropion |
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Liraglutide | Drug | dose of 3 mg subcutaneous daily |
|
|
| Naltrexone/bupropion | Drug | Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) |
|
|
| Phentermine | Drug | 15-37.5 mg oral daily |
|
|
| baseline to 12 weeks |
| BG001 | Control Group | Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) Phentermine: 15-37.5 mg oral daily |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Responders | Percentage of participants who loss 5% or more of total body weight | Posted | Number | percentage of participants | baseline to 12 weeks |
|
|
|
| Secondary | Percentage of Responders | Percentage of participants with at least 10% total body weight loss | Posted | Number | percentage of participants | baseline to 12 weeks |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 23 |
| 93 |
| EG001 | Control Group | Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) Phentermine: 15-37.5 mg oral daily | 0 | 100 | 0 | 100 | 25 | 100 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |