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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754OBE2002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin + Phentermine | Experimental | 300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks. |
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| Canagliflozin + Placebo (Phentermine) | Experimental | 300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks. |
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| Phentermine + Placebo (Canagliflozin) | Experimental | 15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks. |
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| Placebo | Placebo Comparator | Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug | 300 mg capsule, taken once daily, orally for 26 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight at Week 26 | The percent change from baseline in body weight at Week 26 was analysed. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26 | Percentage of participants with weight loss >= 5 percent were analysed at week 26. | Week 26 |
| Change From Baseline in Systolic Blood Pressure at Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | Change from baseline in diastolic blood pressure (DBP) at week 26. | Week 26 |
| Change From Baseline in Pulse Rate at Week 26 | Change from baseline in pulse rate at week 26 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Between screening and randomisation, eligible subjects were included in a 4-week single-blind run-in period in which all subjects were placed on a hypocaloric diet.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo tablets orally for 26 weeks. |
| FG001 | Phentermine 15 mg | Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Phentermine | Drug | 15 mg capsule, taken once daily, orally for 26 weeks. |
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| Matching Placebo to Canagliflozin | Drug | Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks. |
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| Matching Placebo to Phentermine | Drug | Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks. |
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Change from baseline in systolic blood pressure was analysed at week 26.
| Week 26 |
| Absolute Change From Baseline in Body Weight at Week 26 | Absolute change from baseline in body weight was analysed at week 26. | Week 26 |
| Week 26 |
| Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26 | Percentage of participants with weight loss >= 10 percent at week 26. | Week 26 |
| Walnut Creek |
| California |
| United States |
| Jacksonville | Florida | United States |
| Meridian | Idaho | United States |
| Evansville | Indiana | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Milford | Massachusetts | United States |
| Manlius | New York | United States |
| Warwick | Rhode Island | United States |
| Mt. Pleasant | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Odessa | Texas | United States |
| Norfolk | Virginia | United States |
| Wauwatosa | Wisconsin | United States |
| FG002 | Canagliflozin 300 mg | Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks. |
| FG003 | Canagliflozin 300 mg/Phentermine 15 mg | Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo tablets orally for 26 weeks. |
| BG001 | Phentermine 15 mg | Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks. |
| BG002 | Canagliflozin 300 mg | Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks. |
| BG003 | Canagliflozin 300 mg/Phentermine 15 mg | Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks. |
| BG004 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Weight | Mean | Standard Deviation | Kilogram [kg] |
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| Baseline Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per meter square [kg/m²] |
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| Baseline Systolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury [mmHg] |
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| Baseline Diastolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury [mmHg] |
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| Baseline Pulse Rate | Mean | Standard Deviation | (BEATS/MIN) |
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| 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 From Baseline in Body Weight at Week 26 | The percent change from baseline in body weight at Week 26 was analysed. | The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Percent Change | Week 26 |
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| Secondary | Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26 | Percentage of participants with weight loss >= 5 percent were analysed at week 26. | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Change From Baseline in Systolic Blood Pressure at Week 26 | Change from baseline in systolic blood pressure was analysed at week 26. | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | Week 26 |
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| Secondary | Absolute Change From Baseline in Body Weight at Week 26 | Absolute change from baseline in body weight was analysed at week 26. | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Kilogram (Kg) | Week 26 |
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| Other Pre-specified | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | Change from baseline in diastolic blood pressure (DBP) at week 26. | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | Week 26 |
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| Other Pre-specified | Change From Baseline in Pulse Rate at Week 26 | Change from baseline in pulse rate at week 26 | The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Beats Per Minute (Beats/Min) | Week 26 |
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| Other Pre-specified | Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26 | Percentage of participants with weight loss >= 10 percent at week 26. | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. | Posted | Number | Percentage of Participants | Week 26 |
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Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
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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 | Placebo | Participants received placebo tablets orally for 26 weeks. | 0 | 82 | 41 | 82 | ||
| EG001 | Phentermine 15 mg | Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks. | 0 | 85 | 37 | 85 | ||
| EG002 | Canagliflozin 300 mg | Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks. | 0 | 84 | 42 | 84 | ||
| EG003 | Canagliflozin 300 mg/Phentermine 15 mg | Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks. | 1 | 83 | 42 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Acute Sinusitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Pharyngitis Streptococcal | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Tooth Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Vulvovaginal Candidiasis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Tension Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
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| Male |
|
| 0.142 |
| Least Square Mean Difference |
| -1.3 |
| Standard Error of the Mean |
| 0.9 |
| 2-Sided |
| 95 |
| -3.1 |
| 0.4 |
| No |
| Superiority or Other |
| Mixed Model for Repeated Measures | <0.001 | Least Square Mean Difference | -6.9 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -8.6 | -5.2 | No | Superiority or Other |
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| Units | Counts |
|---|---|
| Participants |
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