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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK119456 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.
This project is studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. All participants start with a lifestyle modification program and some participants may also receive study medication.Participants must be 12-17 years of age and carry extra weight. The program will last for 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSMT 12 | Other | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 36 weeks); if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study. |
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| LSMT 24 | Other | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study. If BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Modification Therapy (LSMT) | Behavioral | LSMT will consist of both in-person and by telephone sessions delivered throughout the 48-week intervention phase. Each session will last 30-60 minutes. A trained study coordinator (a registered dietician or someone trained by our registered dietician) will deliver therapy which consists of counseling using education, goal setting and barrier reduction. Participants will be randomized to receive LSMT for 12 or 24 weeks before a re-assessment of their BMI. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Mass Index (BMI) | The outcome values represent percent change in BMI from baseline to week 48. | Baseline to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Fox, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
De-identified IPD may be shared.
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Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and telephone sessions delivered throughout the entirety of the 48-week intervention. Sessions will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks.
Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48.
Participants were recruited in the Pediatric Weight Management Clinic, by flyers and recruitment letters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: LSMT 12 | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study. |
| FG001 | Arm 1: LSMT 12 + Phentermine | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. |
| FG002 | Arm 1: LSMT 12+Phentermine+Topiramate | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. At 24 weeks, if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. |
| FG003 | Arm 1: LSMT 12+ Topiramate + Placebo | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. At 24 weeks, if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+placebo+LSMT for the remainder of the study. |
| FG004 | Arm 2: LSMT 24 | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 24 weeks) |
| FG005 | Arm 2: LSMT 24 + Phentermine | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. |
| FG006 | Arm 2: LSMT 24+Phentermine+Topiramate | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT for the duration of the study |
| FG007 | Arm 2: LSMT+Topiramate+Placebo | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: LSMT 12 | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. |
| 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 | Participants were aged 12-17 at the time of consenting. |
| 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 | Percent Change in Body Mass Index (BMI) | The outcome values represent percent change in BMI from baseline to week 48. | Posted | Mean | Standard Deviation | % change in body mass index (BMI) | Baseline to Week 48 |
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Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
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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 | Arm 1: LSMT x 12 | Participants will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study. Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and Infestations: Other | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Fox | University of Minnesota | 612-626-6616 | lusc0001@umn.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 | Jul 1, 2024 | Feb 26, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2023 | May 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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2-staged sequential multiple assignment randomized trial
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At baseline, each participant will be randomized 1:1 to either the 12-week (Arm 1) or 24-week (Arm 2) response assessment to LSMT. This randomization will be blinded to the participant, investigator, and outcomes assessor for the duration of the study; i.e. up until 48 weeks.
The second randomization includes only those participants who are non-responders to phentermine+LSMT. Each non-responder to phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants, investigators, and outcomes assessors will be blinded to phentermine/placebo. The topiramate will be open label.
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| Phentermine Pill | Drug | Phentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study (through week 48) along with their LSMT. |
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| Topiramate Pill | Drug | Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
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| Placebo | Drug | Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants will take a placebo pill every morning. |
|
| Withdrawal by Subject |
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| Physician Decision |
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| BG001 | Arm 1: LSMT 12+Phentermine | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT. |
| BG002 | Arm 1: LSMT 12+Phentermine+Topiramate | If BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT. Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
| BG003 | Arm 1: LSMT+Topiramate+Placebo | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
| BG004 | Arm 2: LSMT 24 | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. |
| BG005 | Arm 2: LSMT 24+Phentermine | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT. |
| BG006 | Arm 2: LSMT 24+Phentermine+Topiramate | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: when BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. If BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT. Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
| BG007 | Arm 2: LSMT 24+Topiramate+Placebo | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: when BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. If BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes. Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
| BG008 | Total | Total of all reporting groups |
| Count of Participants |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | LSMT 12+Phentermine+Topiramate | At 24 weeks if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Phentermine Pill: Subjects will take 15 mg of phentermine every morning. Topiramate Pill: Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
| OG003 | LSMT 12+Topiramate+Placebo | At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Topiramate Pill: Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. Placebo Pill: Participant will take one placebo pill each morning. |
| OG004 | LSMT 24 | Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment at 36 weeks. |
| OG005 | LSMT 24+Phentermine | At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Phentermine Pill: Phentermine will be started only if a participant does not lose 5% of BMI after 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning. |
| OG006 | LSMT 24+Phentermine+Topiramate | At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Phentermine Pill: Phentermine will be started only if a participant does not lose 5% of BMI after 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning. Topiramate Pill: Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. |
| OG007 | LSMT+Topiramate+Placebo | At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Topiramate Pill:Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue. Placebo Pill: Participants will take one placebo pill in the morning. |
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| 0 |
| 11 |
| 1 |
| 11 |
| 11 |
| 11 |
| EG001 | Arm 1: LSMT 12 +Phentermine | Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT. | 0 | 24 | 2 | 24 | 20 | 24 |
| EG002 | Arm 1: LSMT +12+Phentermine+Topiramate | Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT. Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue. | 0 | 20 | 3 | 20 | 20 | 20 |
| EG003 | Arm 1: LSMT 12+Phentermine+Placebo | Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue. | 0 | 21 | 1 | 21 | 21 | 21 |
| EG004 | Arm 2: LSMT x 24 | Participants in this arm will start LSMT at baseline and have a weight loss assessment at 24 weeks: if BMI is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study. Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT. Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue. | 0 | 16 | 2 | 16 | 16 | 16 |
| EG005 | Arm 2: LSMT 24+Phentermine | Participants in this arm will start LSMT at baseline and have a weight loss assessment at 24 weeks; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT. | 0 | 19 | 0 | 19 | 19 | 19 |
| EG006 | Arm 2: LSMT 24X Phentermine+Topiramate | Participants in this arm be assessed at 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT. Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue. | 0 | 20 | 0 | 20 | 20 | 20 |
| EG007 | Arm 2: LSMT 24+Phentermine+Placebo | Participants in this arm be assessed at 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT. Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue. | 0 | 19 | 0 | 19 | 19 | 19 |
| Cholecystectomy | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Status Asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Foodborne Illness | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Self-Injurious Behavior | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Auditory Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Psychiatric Disorders: Other | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Paresthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headaches | Nervous system disorders | MedDRA | Systematic Assessment |
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| Depressed Mood | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Injury, poisoning, and procedural complications: other | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Sleepiness/fatigue | General disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal Disorders: Other | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Difficulty focusing or concentrating | Nervous system disorders | MedDRA | Systematic Assessment |
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| Agitation/Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |