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Results from previous study DFA102 demonstrated neutralizing activity to metreleptin in invitro assay in 2 participants.
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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Pramlintide+Metreleptin |
|
| Group B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramlintide+Metreleptin | Drug | Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once. | Day 1 up to Month 6 Follow-Up |
| Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL). | Baseline to Month 6 Follow Up |
| Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population | Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin. | Week 1 to Month 6 Follow-Up |
| Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin | In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin. | Baseline to Month 6 Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. | Baseline up to Month 6 Follow-Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Vice President, Research & Development | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Greenbrae | California | United States | |||
| Research Site |
6 week lead-in period:low-calorie diet (LCD); 16 week randomized treatment period: participants who lost >=2% body weight at end of LCD were randomized to an arm. Sponsor terminated study during randomization period due to neutralizing activity to metreleptin observed in Study DFA102, NCT00673387. Safety follow-up 2, 4, 6 months post treatment.
5 January 2011 Lead-In Period started. 28 September 2011 last participants final visit procedure. Clinics where participants with body mass index [BMI] greater than, equal to (≥)35 kilogram per meter squared (kg/m^2) and less than, equal to (≤)45 kg/m2) could be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Calorie Diet Only | 6 Week Lead-in Period with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to either study drug or placebo in the Randomization period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Non-Randomized Low Calorie Diet Lead-In |
|
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| Placebo | Drug | Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses. |
|
| Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - 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. |
| Screening to 6 Month Follow-Up |
| Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population | Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or 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 Month 6 Follow-Up |
| Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg). | Baseline to Month 6 Follow-Up |
| Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min). | Baseline up to Month 6 Follow-Up |
| Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL). | Baseline to 6 Month Follow-Up |
| Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L). | Baseline up to Month 6 Follow-Up |
| Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL). | Baseline up to Month 6 Follow-Up |
| La Jolla |
| California |
| United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Hyattsville | Maryland | United States |
| Research Site | Boston | Massachusetts | 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 | Tulsa | Oklahoma | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Arlington | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Placebo |
Self administered subcutaneous (SC) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks. |
| FG002 | Pramlintide + Metreleptin | Self administered SC injection of pramlintide 360 micrograms (µg) + metreleptin 5.0 milligrams (mg) BID for 16 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomized to Treatment |
|
|
| Follow-Up Post Treatment up to Month 6 |
|
|
Baseline for all participants (213) was baseline at enrollment (Day 1 of Lead-in period); baseline for participants who were randomized to treatment before study was terminated was Day 1 of randomization (last measurement before first dose of assigned drug).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Non-Randomized Lead-in LCD | 6 Week Lead-in with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to study drug in the Randomization period. |
| BG001 | Placebo | Self administered subcutaneous (SC ) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks. |
| BG002 | Pramlintide + Metreleptin | Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks |
| BG003 | 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 | Age at Screening is presented. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Weight | Body weight at enrollment measured in kilograms (kg). | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index | Body Mass Index (BMI) at enrollment measured in kilograms per meter of height squared (kg/m^2). | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively. | Posted | Mean | Standard Deviation | percentage of change in weight | Baseline up to Month 6 Follow-Up |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once. | The intent to treat (ITT) population received at least one dose of randomized study treatment. | Posted | Number | participants | Day 1 up to Month 6 Follow-Up |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL). | All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively. | Posted | Mean | Standard Deviation | ng/mL | Baseline to Month 6 Follow Up |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population | Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin. | All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28. | Posted | Number | participants | Week 1 to Month 6 Follow-Up |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin | In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin. | Posted | Number | participants | Baseline to Month 6 Follow-Up |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - 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. | The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively. | Posted | Number | participants | Screening to 6 Month Follow-Up |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population | Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or 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. | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement. | Posted | Number | participants | Screening to Month 6 Follow-Up |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg). | The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up. | Posted | Mean | Standard Deviation | mmHg | Baseline to Month 6 Follow-Up |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min). | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement. | Posted | Mean | Standard Deviation | beats/min | Baseline up to Month 6 Follow-Up |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL). | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up. | Posted | Mean | Standard Deviation | mg/dL | Baseline to 6 Month Follow-Up |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L). | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement. | Posted | Mean | Standard Deviation | mU/L | Baseline up to Month 6 Follow-Up |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population | Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL). | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up. | Posted | Mean | Standard Deviation | mg/dL | Baseline up to Month 6 Follow-Up |
|
|
Treatment emergent adverse events (AEs) and Serious AEs (SAEs): onset date/ time on or after first dose of randomized study medication and on or before the last dose of randomized study medication.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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-P + Placebo-M | Self administered subcutaneous injection once a day (QD) of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) for 1 week followed by BID dosing for 15 weeks (16 weeks total). | 0 | 36 | 1 | 36 | ||
| EG001 | Pramlintide + Metreleptin | Self administered subcutaneous injection once a day (QD) of pramlintide 360 micrograms (µg) plus metreleptin 5.0 milligrams (mg ) for 1 week followed by twice a week (BID) dosing for 15 weeks (Total of 16 Weeks treatment). | 1 | 36 | 14 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| injection site hematoma | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| injection site induration | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| injection site pruritus | General disorders | MedDRA (14.0) | Non-systematic Assessment |
|
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 |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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
| Sponsor terminated study |
|
| Other |
|
| Male |
|
| OG003 | Post Treatment Pramlintide + Metreleptin Arm | From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment. |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
|
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