Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-P + Placebo-M | Placebo Comparator | Placebo matched to pramlintide BID plus placebo matched to metreleptin BID |
|
| Pramlintide 360 mcg + Placebo-M | Experimental | 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID |
|
| Placebo-P + Metreleptin 5.0 mg | Experimental | Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID |
|
| Pramlintide 180 mcg + Metreleptin 2.5 mg | Experimental | Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID |
|
| Pramlintide 180 mcg + Metreleptin 5.0 mg | Experimental | Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID |
|
| Pramlintide 360 mcg + Metreleptin 1.25 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramlintide acetate | Drug | subcutaneous injection, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups). | Baseline to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. | Baseline to Week 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vice President Research and Development, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26589105 | Derived | Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2. |
Not provided
Not provided
Participants enrolled, not randomized /treated (28): withdrew consent (10), adverse event (1), investigator decision (7), protocol violation (4), lost to follow up (5), administrative (1). 1 Week Lead-in Period: all arms received placebo matched to metreleptin and matched to pramlintide, BID (single blind); 28 week double blind Treatment Period.
First participant dosed/lead in: 06 May 2008; last participant's final visit: 07 April 2009. Study conducted in 42 clinics in participants who were either obese (body mass index (BMI) greater than, equal to (>=) 30 kg/m^2 and less than equal to (<=) 45 kg/m^2) or overweight (>= 27 kg/m^2 and < 30 kg/m^2).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M). |
| FG001 | Pramlintide 360 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID |
|
| Pramlintide 360 mcg + Metreleptin 2.5 mg | Experimental | Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID |
|
| Pramlintide 360 mcg + Metreleptin 5.0 mg | Experimental | Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID |
|
|
| metreleptin | Drug | subcutaneous injection, twice a day |
|
| placebo-P | Drug | subcutaneous injection, twice a day |
|
|
| placebo-M | Drug | subcutaneous injection, twice a day |
|
|
| Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population |
Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. |
| Baseline to Week 28 |
| LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population | Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. | Baseline to Week 28 |
| LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population | Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm). | Baseline to Weeks 12 and Week 28 |
| Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms*hour/milliliter (pg*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection. | Week 4 and Week 24 |
| Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide | Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms*hour/milliliter (pg*h/mL). | Weeks 4 and 24 |
| Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL). | Week 4 and Week 24 |
| Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population | Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline. | Baseline to Week 28 |
| LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population | Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k). | Baseline to Week 28 |
| LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population | Parameters of body composition were measured with a Dual Energy X-ray Absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Fat-free mass were measured in kilogram (k). | Baseline to Week 28 |
| LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population | Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. All parameters were measured in milligrams per deciliter (mg/dL). | Baseline to Week 28 |
| Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population | Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. Parameter was measured micro international units per milliliter. (µIU/mL). | Baseline to Week 28 |
| Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population | Subjective effects of weight loss were measured using the IWQOL-Lite questionnaire, a 31-item patient reported outcome (PRO) instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items have a range of 1 to 5 with 5=always true and 1= never true. The total score for the IWQOL-Lite instrument is measured on a scale from 0 (worst) to 100 (best). Higher scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period. | Screening to Week 24 |
| Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population | The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. The minimum and maximum score for the BES instrument is 0 and 55, respectively. The higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period. | Screening to Week 24 |
| Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population | The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale (ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores indicate improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period. | Screening to Week 24 |
| Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population | The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The higher the score, the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period | Screening to Week 24 |
| Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population | The POMS is a mood scale consisting of 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each of the six POMS factors. The mood adjectives load onto 6 mood factors, which are as follows: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. The factor scores are added to obtain the total mood disturbance score. A lower total mood disturbance score indicates improvement. Values were obtained for this questionnaire on Visit 3 in the screening period. | Screening to Week 24 |
| Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population | The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire which assesses sleep quality and sleep disturbances over a period of 1 month. The PSQI provides ratings on seven domains of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). The sum of the individual domains yields a global sleep quality score with a range of 0-21. A PSQI score >5 is indicative of poor sleep, which is characterized by severe difficulties in at least two domains, or moderate difficulties in three or more domains. Values were obtained for this questionnaire on Visit 3 in the screening period. | Screening to Week 24 |
| Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population | The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period | Screening to Week 24 |
| Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population | Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of values are cumulative across the study. | Screening to Week 28 |
| Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population | Obtained at: Screening, Days -7, 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of laboratory values are cumulative across the study. Criteria for values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma/serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. | Screening to Week 28 |
| Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population | Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28 | Baseline to Week 28 |
| Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population | Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. | Baseline to Week 28 |
| Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population | Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline. | Baseline to Week 28 |
| Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population | A 12-Lead electrocardiogram (ECG) was obtained at Screening, Day 1, Weeks 1, 12, 28 (study termination). The PR interval, which is time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval (time from the beginning to the end of the QRS complex); QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). | Screening to Week 28 (or study termination) |
| Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population | A 12-Lead electrocardiogram (ECG) was obtained at Screening (visit 2), Day 1, Weeks 1, 12, 28 (study termination). Heart Rate was measured in beats per min (bpm). | Screening to Week 28 (or early termination) |
| Chandler |
| Arizona |
| United States |
| Research Site | Santa Rosa | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Pembrook Pines | Florida | United States |
| Research Site | Plantation | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Auburn | Maine | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Edina | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Butte | Montana | United States |
| Research Site | New York | New York | United States |
| Research Site | Statesville | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Anderson | South Carolina | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Mt. Pleasant | South Carolina | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Belingham | Washington | United States |
| Research Site | Olympia | Washington | United States |
Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
| FG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| FG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| FG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| FG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| FG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| FG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat population. All participants randomized to a treatment and received at least 1 dose. Drug Randomization stratified:sex,3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total:8 treatment groups).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M). |
| BG001 | Pramlintide 360 mcg | Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| BG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| BG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| BG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| BG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| BG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| BG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Body Mass Index (BMI)calculated using baseline weight and height; BMI = kg body weight/meters of height^2. Weight, height measured on Day 1. If Day 1 value missing or value obtained after the first dose, the last available value prior to Day 1 was used. | Mean | Standard Deviation | (kg/m^2) |
|
| 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 | Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups). | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change in kg | Baseline to Week 28 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | Posted | Number | participants | Baseline to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population | Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. | Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented. | Posted | Mean | Standard Deviation | ng/mL | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population | Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population | Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm). | Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively. | Posted | Least Squares Mean | Standard Error | cm | Baseline to Weeks 12 and Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms*hour/milliliter (pg*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection. | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36. | Posted | Geometric Mean | Standard Error | pg*h/mL | Week 4 and Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide | Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms*hour/milliliter (pg*h/mL). | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively. | Posted | Geometric Mean | Standard Error | pg*h/mL | Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL). | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively. | Posted | Geometric Mean | Standard Error | pg/mL | Week 4 and Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population | Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline. | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | Posted | Least Squares Mean | Standard Error | percentage of body fat | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population | Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k). | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | Posted | Least Squares Mean | Standard Error | kg | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population | Parameters of body composition were measured with a Dual Energy X-ray Absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Fat-free mass were measured in kilogram (k). | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | Posted | Least Squares Mean | Standard Error | kg | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population | Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. All parameters were measured in milligrams per deciliter (mg/dL). | Evaluable population: received at least one dose of randomized treatment, had adequate exposure to treatment, complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) presented above for TC, LDL and HDL cholesterol. Glucose n= 43, 50, 41, 46, 45, 43,44,36; Triglycerides n= 44,50,41,46,45,44,44.38. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population | Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. Parameter was measured micro international units per milliliter. (µIU/mL). | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population | Subjective effects of weight loss were measured using the IWQOL-Lite questionnaire, a 31-item patient reported outcome (PRO) instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items have a range of 1 to 5 with 5=always true and 1= never true. The total score for the IWQOL-Lite instrument is measured on a scale from 0 (worst) to 100 (best). Higher scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period. | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Deviation | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population | The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. The minimum and maximum score for the BES instrument is 0 and 55, respectively. The higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period. | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Deviation | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population | The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale (ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores indicate improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period. | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Deviation | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population | The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The higher the score, the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Error | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population | The POMS is a mood scale consisting of 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each of the six POMS factors. The mood adjectives load onto 6 mood factors, which are as follows: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. The factor scores are added to obtain the total mood disturbance score. A lower total mood disturbance score indicates improvement. Values were obtained for this questionnaire on Visit 3 in the screening period. | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Error | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population | The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire which assesses sleep quality and sleep disturbances over a period of 1 month. The PSQI provides ratings on seven domains of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). The sum of the individual domains yields a global sleep quality score with a range of 0-21. A PSQI score >5 is indicative of poor sleep, which is characterized by severe difficulties in at least two domains, or moderate difficulties in three or more domains. Values were obtained for this questionnaire on Visit 3 in the screening period. | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Deviation | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population | The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | Posted | Mean | Standard Error | units on a scale | Screening to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population | Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of values are cumulative across the study. | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Number | Number of Laboratory Values | Screening to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population | Obtained at: Screening, Days -7, 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of laboratory values are cumulative across the study. Criteria for values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma/serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Number | Number of Laboratory Values | Screening to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population | Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28 | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Mean | Standard Deviation | mm Hg | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population | Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Mean | Standard Deviation | bpm | Baseline to Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population | Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline. | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Number | participants | Baseline to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population | A 12-Lead electrocardiogram (ECG) was obtained at Screening, Day 1, Weeks 1, 12, 28 (study termination). The PR interval, which is time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval (time from the beginning to the end of the QRS complex); QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Mean | Standard Deviation | msec | Screening to Week 28 (or study termination) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population | A 12-Lead electrocardiogram (ECG) was obtained at Screening (visit 2), Day 1, Weeks 1, 12, 28 (study termination). Heart Rate was measured in beats per min (bpm). | Intent to treat population included all randomized participants who received at least one injection of study medication. | Posted | Mean | Standard Deviation | bpm | Screening to Week 28 (or early termination) |
|
From enrollment to Study Termination (Week 28). Clinically significant events that continued beyond termination were followed until diagnosis/resolution occurred. Serious adverse events were followed 30 days post last dose of study medication.
All participants enrolled were treated with Placebo for 1 week and then randomized into a treatment group. Enrolled = 636 (commenced placebo for 1 week); Enrolled but not randomized = 28; Randomized = 608; Intent to treat = Randomized and received at least 1 dose. Events presented below from Randomized population, treatment-emergent (ITT).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M). | 3 | 75 | 60 | 75 | ||
| EG001 | Pramlintide 360 mcg | Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). | 1 | 77 | 66 | 77 | ||
| EG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). | 0 | 72 | 63 | 72 | ||
| EG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. | 2 | 75 | 67 | 75 | ||
| EG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. | 0 | 78 | 71 | 78 | ||
| EG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). | 0 | 78 | 68 | 78 | ||
| EG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). | 0 | 78 | 72 | 78 | ||
| EG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). | 2 | 75 | 68 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food Allergy | Immune system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Parathyroid Tumor benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Goiter | Endocrine disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| injection site erythema | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| injection site pruritus | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| injection site bruising | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| injection site hemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| injection site urticaria | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| injection site rash | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| injection site nodule | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| blood creatine phosphokinase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| injection site induration | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| injection site inflammation | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| fatigue | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| gastroenteritis viral | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Drug Randomization stratified:sex,3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total:8 treatment groups).
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C105254 | pramlintide |
| C415771 | metreleptin |
Not provided
Not provided
Not provided
| Male |
|
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.0002 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.0004 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| t-test, 2 sided | <0.0001 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| t-test, 2 sided | 0.0001 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.2510 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.3433 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.4503 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.2122 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.2232 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.4207 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion. | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858% | t-test, 2 sided | 0.5375 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion. | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858% | t-test, 2 sided | 0.6633 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.3667 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion | No | Superiority or Other |
| When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%. | t-test, 2 sided | 0.3720 | unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion. | No | Superiority or Other |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
| OG002 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG003 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG004 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG005 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
|
Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
| OG002 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG003 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG004 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG005 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 |
| Pramlintide 180 mcg + Metreleptin 5.0 mg |
Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG003 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG004 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG005 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG003 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG004 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG005 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| Metreleptin 5.0 mg |
Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| Pramlintide 180 mcg + Metreleptin 5.0 mg |
Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg |
| OG003 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG004 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG005 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG002 | Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P). |
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|
| OG003 | Pramlintide 180 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg. |
| OG004 | Pramlintide 180 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg. |
| OG005 | Pramlintide 360 mcg + Metreleptin 1.25 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG006 | Pramlintide 360 mcg + Metreleptin 2.5 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
| OG007 | Pramlintide 360 mcg + Metreleptin 5.0 mg | Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant). |
|
|