CompletedPhase 2Results posted

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects.

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Actual enrollment

636

Study population

Obesity / overweight

Eligibility highlights

•BMI 30-35

Primary endpoint

•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00673387

Org study IDDFA102

Timeline

Milestones

Study first posted2008-05-07estimated

Results first posted2013-11-14estimated

Last update posted2015-04-15estimated

Study start2008-04 (month precision)

Primary completion2009-04actual (month precision)

Study completion2009-10actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•18 to 65 years old.

•Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight (BMI>=27kg/m^2 and <30kg/m^2.

•Has stable body weight, i.e., not varying by >3% within 3 months prior to study.

•Has not been treated over the past 3 months or is currently treated with any of the following medications: Oral contraceptives (female subjects); Hormone replacement therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement therapy; selective serotonin reuptake inhibitors (SSRIs).

•Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study.

•Is a nonsmoker (has not smoked for at least 6 months prior to the study).

Exclusion criteria

•Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics suggestive of genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet-Biedl syndrome).

•Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion)

•Has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with *antiobesity agents (prescription or over-the-counter), *antipsychotic agents, *antiepileptic agents, *antidepressant agents, *drugs that directly affect gastrointestinal motility, *antidiabetic medications.

•Has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®).

•Has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting.

•Has had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study.

•Has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.

Endpoints (27)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

7 endpoints

Primary/protocol endpoint

Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population

Time frame:Baseline to Week 28

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Least-squares mean · Percentage change in kg	95% CI
Placebo	-2.01	-3.76 - -0.26
Pramlintide 360 mcg	-5.47	-7.19 - -3.76
Metreleptin 5.0 mg	-5.83	-7.72 - -3.95
Pramlintide 180 mcg + Metreleptin 2.5 mg	-6.85	-8.61 - -5.08
Pramlintide 180 mcg + Metreleptin 5.0 mg	-6.61	-8.41 - -4.82
Pramlintide 360 mcg + Metreleptin 1.25 mg	-6.39	-8.18 - -4.59
Pramlintide 360 mcg + Metreleptin 2.5 mg	-6.98	-8.79 - -5.17
Pramlintide 360 mcg + Metreleptin 5.0 mg	-7.02	-8.94 - -5.10

p<0.0001t-test, 2 sided

p0.0002t-test, 2 sided

p0.0004t-test, 2 sided

p<0.0001t-test, 2 sided

p0.0001t-test, 2 sided

p0.2510t-test, 2 sided

p0.3433t-test, 2 sided

p0.4503t-test, 2 sided

p0.2122t-test, 2 sided

p0.2232t-test, 2 sided

p0.4207t-test, 2 sided

p0.5375t-test, 2 sided

p0.6633t-test, 2 sided

p0.3667t-test, 2 sided

p0.3720t-test, 2 sided

Secondary/protocol endpoint

Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population

Time frame:Baseline to Week 28

threshold achievement, improvement

components≥5% weight-loss responders, ≥10% weight-loss responders

Posted result

Group	Number · participants	95% CI
PlaceboWeight Loss >=5%	10	-
Weight Loss >=5% and <10%	7	-
Weight Loss >=10%	3	-
Weight Gain	17	-
No Weight Change or Weight Loss <5%	20	-
Pramlintide 360 mcgWeight Loss >=5%	27	-
Weight Loss >=5% and <10%	14	-
Weight Loss >=10%	13	-
Weight Gain	7	-
No Weight Change or Weight Loss <5%	17	-
Metreleptin 5.0 mgWeight Loss >=5%	18	-
Weight Loss >=5% and <10%	6	-
Weight Loss >=10%	12	-
Weight Gain	7	-
No Weight Change or Weight Loss <5%	16	-
Pramlintide 180 mcg + Metreleptin 2.5 mgWeight Loss >=5%	27	-
Weight Loss >=5% and <10%	14	-
Weight Loss >=10%	13	-
Weight Gain	4	-
No Weight Change or Weight Loss <5%	16	-
Pramlintide 180 mcg + Metreleptin 5.0 mgWeight Loss >=5%	27	-
Weight Loss >=5% and <10%	15	-
Weight Loss >=10%	12	-
Weight Gain	8	-
No Weight Change or Weight Loss <5%	11	-
Pramlintide 360 mcg + Metreleptin 1.25 mgWeight Loss >=5%	23	-
Weight Loss >=5% and <10%	15	-
Weight Loss >=10%	8	-
Weight Gain	5	-
No Weight Change or Weight Loss <5%	17	-
Pramlintide 360 mcg + Metreleptin 2.5 mgWeight Loss >=5%	29	-
Weight Loss >=5% and <10%	15	-
Weight Loss >=10%	14	-
Weight Gain	4	-
No Weight Change or Weight Loss <5%	12	-
Pramlintide 360 mcg + Metreleptin 5.0 mgWeight Loss >=5%	25	-
Weight Loss >=5% and <10%	12	-
Weight Loss >=10%	13	-
Weight Gain	3	-
No Weight Change or Weight Loss <5%	10	-

Secondary/protocol endpoint

LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population

Time frame:Baseline to Week 28

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
PlaceboChange at Week 4	-1.81	-2.38 - -1.24
Change at Week 12	-3.39	-4.50 - -2.28
Change at Week 28	-2.04	-3.82 - -0.26
Pramlintide 360 mcgChange at Week 4	-2.85	-3.41 - -2.29
Change at Week 12	-4.90	-5.97 - -3.83
Change at Week 28	-5.66	-7.40 - -3.92
Metreleptin 5.0 mgChange at Week 4	-2.54	-3.15 - -1.92
Change at Week 12	-5.13	-6.31 - -3.95
Change at Week 28	-6.18	-8.10 - -4.27
Pramlintide 180 mcg + Metreleptin 2.5 mgChange at Week 4	-2.94	-3.51 - -2.36
Change at Week 12	-5.52	-6.63 - -4.42
Change at Week 28	-6.96	-8.75 - -5.17
Pramlintide 180 mcg + Metreleptin 5.0 mgChange at Week 4	-2.40	-2.99 - -1.82
Change at Week 12	-4.53	-5.65 - -4.41
Change at Week 28	-6.55	-8.38 - -4.72
Pramlintide 360 mcg + Metreleptin 1.25 mgChange at Week 4	-2.62	-3.21 - -2.04
Change at Week 12	-5.52	-6.64 - -4.40
Change at Week 28	-6.38	-8.20 - -4.56
Pramlintide 360 mcg + Metreleptin 2.5 mgChange at Week 4	-3.21	-3.80 - -2.62
Change at Week 12	-5.88	-7.02 - -4.75
Change at Week 28	-7.18	-9.03 - -5.34
Pramlintide 360 mcg + Metreleptin 5.0 mgChange at Week 4	-3.32	-3.95 - -2.69
Change at Week 12	-6.12	-7.32 - -4.92
Change at Week 28	-6.97	-8.92 - -5.02

Secondary/protocol endpoint

LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population

Time frame:Baseline to Weeks 12 and Week 28

Waist circumference, change

change from baseline, improvement

Posted result

Group	Least-squares mean · cm	95% CI
PlaceboChange at Week 12	-3.03	-
Change at Week 28	-2.54	-
Pramlintide 360 mcgChange at Week 12	-3.40	-
Change at Week 28	-3.95	-
Metreleptin 5.0 mgChange at Week 12	-3.41	-
Change at Week 28	-3.86	-
Pramlintide 180 mcg + Metreleptin 2.5 mgChange at Week 12	-4.91	-
Change at Week 28	-5.48	-
Pramlintide 180 mcg + Metreleptin 5.0 mgChange at Week 12	-4.29	-
Change at Week 28	-5.75	-
Pramlintide 360 mcg + Metreleptin 1.25 mgChange at Week 12	-3.32	-
Change at Week 28	-4.70	-
Pramlintide 360 mcg + Metreleptin 2.5 mgChange at Week 12	-4.63	-
Change at Week 28	-5.52	-
Pramlintide 360 mcg + Metreleptin 5.0 mgChange at Week 12	-5.23	-
Change at Week 28	-6.53	-

p0.0404t-test, 2 sided

Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate

p0.0265t-test, 2 sided

Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.

p0.1357t-test, 2 sided

Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.

p0.0409t-test, 2 sided

Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.

p0.0082t-test, 2 sided

Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.

Secondary/protocol endpoint

Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population

Time frame:Baseline to Week 28

Total fat mass

change from baseline, improvement

Posted result

Group	Least-squares mean · percentage of body fat	95% CI
Placebo	-0.95	-
Pramlintide 360 mcg	-1.77	-
Metreleptin 5.0 mg	-1.94	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-2.32	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-2.21	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-2.21	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-1.56	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-2.46	-

p0.0464t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0647t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0690t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.3717t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0327t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

Secondary/protocol endpoint

LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population

Time frame:Baseline to Week 28

Total fat mass

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
Placebo	-1.96	-
Pramlintide 360 mcg	-4.28	-
Metreleptin 5.0 mg	-4.57	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-4.98	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-4.97	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-5.03	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-4.35	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-5.51	-

p0.0049t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0047t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0046t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0257t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0014t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

Secondary/protocol endpoint

LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population

Time frame:Baseline to Week 28

Lean mass

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
Placebo	-0.69	-
Pramlintide 360 mcg	-1.62	-
Metreleptin 5.0 mg	-1.80	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-1.90	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-1.99	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-2.02	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-2.11	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-2.29	-

p0.0222t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0128t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0122t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0073t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

p0.0034t-test, 2 sided

Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population

Time frame:Baseline to Week 28

change from baseline, improvement

Posted result

Group	Least-squares mean · µIU/mL	95% CI
Placebo	1.1	-
Pramlintide 360 mcg	-0.4	-
Metreleptin 5.0 mg	-1.6	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-1.0	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-2.5	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-1.4	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-0.8	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-0.5	-

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population

Time frame:Baseline to Week 28

Leptin, change

change from baseline, improvement

Posted result

Group	Mean · ng/mL	95% CI
Metreleptin 5.0 mgChange from baseline at Week 4	53.26	-
Change from baseline at Week 12	386.48	-
Change from baseline at Week 28	557.22	-
Pramlintide 180 mcg + Metreleptin 2.5 mgChange from baseline at Week 4	31.00	-
Change from baseline at Week 12	167.62	-
Change from baseline at Week 28	373.64	-
Pramlintide 180 mcg + Metreleptin 5.0 mgChange from baseline at Week 4	47.82	-
Change from baseline at Week 12	353.61	-
Change from baseline at Week 28	487.17	-
Pramlintide 360 mcg + Metreleptin 1.25 mgChange from baseline at Week 4	-2.36	-
Change from baseline at Week 12	53.76	-
Change from baseline at Week 28	105.96	-
Pramlintide 360 mcg + Metreleptin 2.5 mgChange from baseline at Week 4	14.66	-
Change from baseline at Week 12	165.65	-
Change from baseline at Week 28	266.02	-
Pramlintide 360 mcg + Metreleptin 5.0 mgChange from baseline at Week 4	49.16	-
Change from baseline at Week 12	399.74	-
Change from baseline at Week 28	393.06	-

Secondary/protocol endpoint

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

Time frame:Baseline to Week 28

change from baseline, improvement

componentsFasting glucose, change, Total cholesterol, change, Triglycerides, change, LDL-C, change, HDL-C, change

Posted result

Group	Least-squares mean · mg/dL	95% CI
PlaceboFasting Plasma Glucose	-1.3	-
Total Cholesterol	4.3	-
Triglycerides	-0.1	-
LDL Cholesterol	4.3	-
HDL Cholesterol	1.5	-
Pramlintide 360 mcgFasting Plasma Glucose	-1.8	-
Total Cholesterol	-7.1	-
Triglycerides	-8.6	-
LDL Cholesterol	-3.5	-
HDL Cholesterol	0.6	-
Metreleptin 5.0 mgFasting Plasma Glucose	-1.8	-
Total Cholesterol	-3.7	-
Triglycerides	-13.0	-
LDL Cholesterol	-2.3	-
HDL Cholesterol	2.6	-
Pramlintide 180 mcg + Metreleptin 2.5 mgFasting Plasma Glucose	-2.5	-
Total Cholesterol	-2.1	-
Triglycerides	-1.4	-
LDL Cholesterol	-3.7	-
HDL Cholesterol	0.7	-
Pramlintide 180 mcg + Metreleptin 5.0 mgFasting Plasma Glucose	-1.2	-
Total Cholesterol	-2.5	-
Triglycerides	-10.9	-
LDL Cholesterol	-0.0	-
HDL Cholesterol	1.0	-
Pramlintide 360 mcg + Metreleptin 1.25 mgFasting Plasma Glucose	-1.0	-
Total Cholesterol	-0.6	-
Triglycerides	11.1	-
LDL Cholesterol	-2.7	-
HDL Cholesterol	2.9	-
Pramlintide 360 mcg + Metreleptin 2.5 mgFasting Plasma Glucose	-1.7	-
Total Cholesterol	-4.0	-
Triglycerides	-9.2	-
LDL Cholesterol	-3.7	-
HDL Cholesterol	0.97	-
Pramlintide 360 mcg + Metreleptin 5.0 mgFasting Plasma Glucose	-1.3	-
Total Cholesterol	-1.3	-
Triglycerides	0.9	-
LDL Cholesterol	-1.2	-
HDL Cholesterol	1.05	-

Secondary/protocol endpoint

Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population

Time frame:Baseline to Week 28

change from baseline, improvement

Posted result

Group	Mean · mm Hg	95% CI
PlaceboSystolic Blood Pressure	2.4	-
Diastolic Blood Pressure	1.2	-
Pramlintide 360 mcgSystolic Blood Pressure	-0.9	-
Diastolic Blood Pressure	-1.7	-
Metreleptin 5.0 mgSystolic Blood Pressure	-3.4	-
Diastolic Blood Pressure	-2.6	-
Pramlintide 180 mcg + Metreleptin 2.5 mgSystolic Blood Pressure	-3.2	-
Diastolic Blood Pressure	-0.4	-
Pramlintide 180 mcg + Metreleptin 5.0 mgSystolic Blood Pressure	0.4	-
Diastolic Blood Pressure	-1.0	-
Pramlintide 360 mcg + Metreleptin 1.25 mgSystolic Blood Pressure	-2.0	-
Diastolic Blood Pressure	-1.3	-
Pramlintide 360 mcg + Metreleptin 2.5 mgSystolic Blood Pressure	-1.2	-
Diastolic Blood Pressure	-1.8	-
Pramlintide 360 mcg + Metreleptin 5.0 mgSystolic Blood Pressure	-1.5	-
Diastolic Blood Pressure	-0.1	-

Secondary/protocol endpoint

Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population

Time frame:Baseline to Week 28

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · bpm	95% CI
Placebo	1.6	-
Pramlintide 360 mcg	-1.3	-
Metreleptin 5.0 mg	-2.6	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-1.4	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-2.1	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-0.5	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-2.4	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-0.1	-

Secondary/protocol endpoint

Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population

Time frame:Screening to Week 28 (or early termination)

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · bpm	95% CI
Placebo	0.3	-
Pramlintide 360 mcg	-2.8	-
Metreleptin 5.0 mg	-4.1	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-4.7	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-4.9	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-1.9	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-6.6	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-3.4	-

Patient-reported / QoL

7 endpoints

Secondary/protocol endpoint

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

Time frame:Screening to Week 24

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
Placebo	10.52	-
Pramlintide 360 mcg	10.31	-
Metreleptin 5.0 mg	11.09	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	10.14	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	16.15	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	13.84	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	13.44	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	11.68	-

Secondary/protocol endpoint

Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population

Time frame:Screening to Week 24

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
Placebo	-3.0	-
Pramlintide 360 mcg	-3.4	-
Metreleptin 5.0 mg	-4.0	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-4.4	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-6.6	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-3.5	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-5.9	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-5.2	-

Secondary/protocol endpoint

Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population

Time frame:Screening to Week 24

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
PlaceboFrequency of Food Cravings	-9.0	-
Strength of Food Cravings	-5.1	-
Difficult to Control Eating	-8.1	-
Difficult to Resist Food Cravings	-11.4	-
Eating in Response to Food Cravings	-11.1	-
Difficult to Control Portion Sizes	-10.8	-
How Hungry	-0.1	-
How Full After Meals	-5.8	-
Thoughts of Food	-2.7	-
How Pleasant Meals	-6.1	-
Pramlintide 360 mcgFrequency of Food Cravings	-6.6	-
Strength of Food Cravings	-6.1	-
Difficult to Control Eating	-15.2	-
Difficult to Resist Food Cravings	-11.1	-
Eating in Response to Food Cravings	-12.2	-
Difficult to Control Portion Sizes	-16.9	-
How Hungry	-9.7	-
How Full After Meals	0.5	-
Thoughts of Food	-10.7	-
How Pleasant Meals	-2.3	-
Metreleptin 5.0 mgFrequency of Food Cravings	-4.0	-
Strength of Food Cravings	-1.1	-
Difficult to Control Eating	-9.5	-
Difficult to Resist Food Cravings	9.6	-
Eating in Response to Food Cravings	-12.6	-
Difficult to Control Portion Sizes	-27.6	-
How Hungry	-17.5	-
How Full After Meals	-7.6	-
Thoughts of Food	-10.6	-
How Pleasant Meals	-2.1	-
Pramlintide 180 mcg + Metreleptin 2.5 mgFrequency of Food Cravings	-14.1	-
Strength of Food Cravings	-13.9	-
Difficult to Control Eating	-19.7	-
Difficult to Resist Food Cravings	-19.5	-
Eating in Response to Food Cravings	-15.4	-
Difficult to Control Portion Sizes	-19.6	-
How Hungry	-16.4	-
How Full After Meals	-3.8	-
Thoughts of Food	-9.4	-
How Pleasant Meals	1.2	-
Pramlintide 180 mcg + Metreleptin 5.0 mgFrequency of Food Cravings	-19.8	-
Strength of Food Cravings	-13.8	-
Difficult to Control Eating	-27.3	-
Difficult to Resist Food Cravings	-21.8	-
Eating in Response to Food Cravings	-22.2	-
Difficult to Control Portion Sizes	-25.2	-
How Hungry	-17.0	-
How Full After Meals	-8.8	-
Thoughts of Food	-16.7	-
How Pleasant Meals	-1.2	-
Pramlintide 360 mcg + Metreleptin 1.25 mgFrequency of Food Cravings	-15.7	-
Strength of Food Cravings	-12.9	-
Difficult to Control Eating	-18.3	-
Difficult to Resist Food Cravings	-19.0	-
Eating in Response to Food Cravings	-18.5	-
Difficult to Control Portion Sizes	-20.8	-
How Hungry	-17.5	-
How Full After Meals	-6.5	-
Thoughts of Food	-12.0	-
How Pleasant Meals	3.7	-
Pramlintide 360 mcg + Metreleptin 2.5 mgFrequency of Food Cravings	-18.5	-
Strength of Food Cravings	-19.6	-
Difficult to Control Eating	-26.3	-
Difficult to Resist Food Cravings	-28.0	-
Eating in Response to Food Cravings	-22.9	-
Difficult to Control Portion Sizes	-24.0	-
How Hungry	-19.2	-
How Full After Meals	-4.2	-
Thoughts of Food	-20.0	-
How Pleasant Meals	5.3	-
Pramlintide 360 mcg + Metreleptin 5.0 mgFrequency of Food Cravings	-13.5	-
Strength of Food Cravings	-15.2	-
Difficult to Control Eating	-18.0	-
Difficult to Resist Food Cravings	-18.2	-
Eating in Response to Food Cravings	-15.9	-
Difficult to Control Portion Sizes	-27.6	-
How Hungry	-19.9	-
How Full After Meals	1.1	-
Thoughts of Food	-5.6	-
How Pleasant Meals	-2.1	-

Secondary/protocol endpoint

Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population

Time frame:Screening to Week 24

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
PlaceboAnxiety Total Scores	0.02	-
Depression Total Scores	-0.85	-
Pramlintide 360 mcgAnxiety Total Scores	0.08	-
Depression Total Scores	-0.76	-
Metreleptin 5.0 mgAnxiety Total Scores	-0.56	-
Depression Total Scores	-0.98	-
Pramlintide 180 mcg + Metreleptin 2.5 mgAnxiety Total Scores	-0.11	-
Depression Total Scores	-0.66	-
Pramlintide 180 mcg + Metreleptin 5.0 mgAnxiety Total Scores	-0.43	-
Depression Total Scores	-1.37	-
Pramlintide 360 mcg + Metreleptin 1.25 mgAnxiety Total Scores	-0.59	-
Depression Total Scores	-1.23	-
Pramlintide 360 mcg + Metreleptin 2.5 mgAnxiety Total Scores	-0.58	-
Depression Total Scores	-1.02	-
Pramlintide 360 mcg + Metreleptin 5.0 mgAnxiety Total Scores	0.06	-
Depression Total Scores	0.00	-

Secondary/protocol endpoint

Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population

Time frame:Screening to Week 24

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
PlaceboTension - Anxiety	0.35	-
Depression - Dejection	0.41	-
Anger - Hostility	0.04	-
Vigor - Activity	1.11	-
Fatigue - Inertia	-1.22	-
Confusion - Bewilderment	0.43	-
Pramlintide 360 mcgTension - Anxiety	0.39	-
Depression - Dejection	0.27	-
Anger - Hostility	0.16	-
Vigor - Activity	0.27	-
Fatigue - Inertia	-0.53	-
Confusion - Bewilderment	0.51	-
Metreleptin 5.0 mgTension - Anxiety	-0.17	-
Depression - Dejection	0.44	-
Anger - Hostility	-0.22	-
Vigor - Activity	0.78	-
Fatigue - Inertia	-1.10	-
Confusion - Bewilderment	0.17	-
Pramlintide 180 mcg + Metreleptin 2.5 mgTension - Anxiety	0.87	-
Depression - Dejection	0.64	-
Anger - Hostility	0.53	-
Vigor - Activity	1.04	-
Fatigue - Inertia	0.02	-
Confusion - Bewilderment	0.40	-
Pramlintide 180 mcg + Metreleptin 5.0 mgTension - Anxiety	-0.30	-
Depression - Dejection	0.26	-
Anger - Hostility	-0.30	-
Vigor - Activity	1.20	-
Fatigue - Inertia	-0.30	-
Confusion - Bewilderment	0.20	-
Pramlintide 360 mcg + Metreleptin 1.25 mgTension - Anxiety	-0.21	-
Depression - Dejection	0.37	-
Anger - Hostility	-0.05	-
Vigor - Activity	0.95	-
Fatigue - Inertia	-1.49	-
Confusion - Bewilderment	0.05	-
Pramlintide 360 mcg + Metreleptin 2.5 mgTension - Anxiety	0.00	-
Depression - Dejection	-0.29	-
Anger - Hostility	-0.18	-
Vigor - Activity	1.13	-
Fatigue - Inertia	-0.82	-
Confusion - Bewilderment	0.02	-
Pramlintide 360 mcg + Metreleptin 5.0 mgTension - Anxiety	0.66	-
Depression - Dejection	0.23	-
Anger - Hostility	0.71	-
Vigor - Activity	1.29	-
Fatigue - Inertia	0.09	-
Confusion - Bewilderment	0.00	-

Secondary/protocol endpoint

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

Time frame:Screening to Week 24

change from baseline, improvement

componentsPGI, change

Posted result

Group	Mean · units on a scale	95% CI
PlaceboMinutes to Fall Asleep	-0.5	-
Hours Asleep	0.1	-
PSQI Global Score	-0.9	-
Pramlintide 360 mcgMinutes to Fall Asleep	1.3	-
Hours Asleep	0.1	-
PSQI Global Score	-0.3	-
Metreleptin 5.0 mgMinutes to Fall Asleep	-2.1	-
Hours Asleep	-0.1	-
PSQI Global Score	-0.3	-
Pramlintide 180 mcg + Metreleptin 2.5 mgMinutes to Fall Asleep	-4.3	-
Hours Asleep	0.2	-
PSQI Global Score	-0.8	-
Pramlintide 180 mcg + Metreleptin 5.0 mgMinutes to Fall Asleep	-4.6	-
Hours Asleep	0.1	-
PSQI Global Score	-0.9	-
Pramlintide 360 mcg + Metreleptin 1.25 mgMinutes to Fall Asleep	-4.3	-
Hours Asleep	0.2	-
PSQI Global Score	-1.0	-
Pramlintide 360 mcg + Metreleptin 2.5 mgMinutes to Fall Asleep	-1.0	-
Hours Asleep	0.2	-
PSQI Global Score	-1.0	-
Pramlintide 360 mcg + Metreleptin 5.0 mgMinutes to Fall Asleep	2.7	-
Hours Asleep	-0.4	-
PSQI Global Score	-0.1	-

Secondary/protocol endpoint

Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population

Time frame:Screening to Week 24

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
Placebo	-0.69	-
Pramlintide 360 mcg	-0.63	-
Metreleptin 5.0 mg	0.12	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	-1.32	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	-1.80	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	-1.05	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	-1.80	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	-0.42	-

Safety / tolerability / PK

7 endpoints

Secondary/protocol endpoint

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

Time frame:Week 4 and Week 24

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · pg*h/mL	95% CI
Pramlintide 360 mcg + Placebo-MWeek 4 AUC (0-tlast)	1862.5	-
Week 24 AUC (0-tlast)	1968.4	-
Pramlintide 180 mcg + Metreleptin 2.5 mgWeek 4 AUC (0-tlast)	878.8	-
Week 24 AUC (0-tlast)	1033.8	-
Pramlintide 180 mcg + Metreleptin 5.0 mgWeek 4 AUC (0-tlast)	967.5	-
Week 24 AUC (0-tlast)	953.7	-
Pramlintide 360 mcg + Metreleptin 1.25 mgWeek 4 AUC (0-tlast)	1788.2	-
Week 24 AUC (0-tlast)	1536.3	-
Pramlintide 360 mcg + Metreleptin 2.5 mgWeek 4 AUC (0-tlast)	1920.1	-
Week 24 AUC (0-tlast)	1990.2	-
Pramlintide 360 mcg + Metreleptin 5.0 mgWeek 4 AUC (0-tlast)	2060.4	-
Week 24 AUC (0-tlast)	1915.3	-

Secondary/protocol endpoint

Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide

Time frame:Weeks 4 and 24

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · pg*h/mL	95% CI
Pramlintide 360 mcg + Placebo-MWeek 4 AUC (0-inf)	2662.7	-
Week 24 AUC (0-inf)	2499.5	-
Pramlintide 180 mcg + Metreleptin 2.5 mgWeek 4 AUC (0-inf)	989.3	-
Week 24 AUC (0-inf)	1175.1	-
Pramlintide 180 mcg + Metreleptin 5.0 mgWeek 4 AUC (0-inf)	1240.7	-
Week 24 AUC (0-inf)	1216.7	-
Pramlintide 360 mcg + Metreleptin 1.25 mgWeek 4 AUC (0-inf)	2159.0	-
Week 24 AUC (0-inf)	1907.5	-
Pramlintide 360 mcg + Metreleptin 2.5 mgWeek 4 AUC (0-inf)	2311.3	-
Week 24 AUC (0-inf)	2411.8	-
Pramlintide 360 mcg + Metreleptin 5.0 mgWeek 4 AUC (0-inf)	2511.4	-
Week 24 AUC (0-inf)	2349.3	-

Secondary/protocol endpoint

Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide

Time frame:Week 4 and Week 24

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · pg/mL	95% CI
Pramlintide 360 mcg + Placebo-MWeek 4 Cmax	1759.0	-
Week 24 Cmax	1985.8	-
Pramlintide 180 mcg + Metreleptin 2.5 mgWeek 4 Cmax	876.7	-
Week 24 Cmax	1048.1	-
Pramlintide 180 mcg + Metreleptin 5.0 mgWeek 4 Cmax	897.3	-
Week 24 Cmax	925.5	-
Pramlintide 360 mcg + Metreleptin 1.25 mgWeek 4 Cmax	1783.8	-
Week 24 Cmax	1573.5	-
Pramlintide 360 mcg + Metreleptin 2.5 mgWeek 4 Cmax	1851.3	-
Week 24 Cmax	2032.0	-
Pramlintide 360 mcg + Metreleptin 5.0 mgWeek 4 Cmax	2096.4	-
Week 24 Cmax	1972.2	-

Secondary/protocol endpoint

Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population

Time frame:Screening to Week 28

event count, event

componentsplatelet count abnormal, hematocrit low, hemoglobin low, wbc count abnormal, urine protein high, urine glucose high, urine ketones high

Posted result

Group	Number · Number of Laboratory Values	95% CI
PlaceboHematocrit	4	-
Hemoglobin	7	-
Platelet Count	0	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	0	-
Urine protein	1	-
Pramlintide 360 mcgHematocrit	0	-
Hemoglobin	0	-
Platelet Count	0	-
White Blood Cell Count	0	-
Urine Glucose	1	-
Urine Ketones	0	-
Urine protein	2	-
Metreleptin 5.0 mgHematocrit	0	-
Hemoglobin	0	-
Platelet Count	1	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	0	-
Urine protein	0	-
Pramlintide 180 mcg + Metreleptin 2.5 mgHematocrit	0	-
Hemoglobin	0	-
Platelet Count	1	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	0	-
Urine protein	2	-
Pramlintide 180 mcg + Metreleptin 5.0 mgHematocrit	0	-
Hemoglobin	0	-
Platelet Count	0	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	0	-
Urine protein	3	-
Pramlintide 360 mcg + Metreleptin 1.25 mgHematocrit	1	-
Hemoglobin	5	-
Platelet Count	0	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	0	-
Urine protein	4	-
Pramlintide 360 mcg + Metreleptin 2.5 mgHematocrit	4	-
Hemoglobin	7	-
Platelet Count	10	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	1	-
Urine protein	2	-
Pramlintide 360 mcg + Metreleptin 5.0 mgHematocrit	3	-
Hemoglobin	4	-
Platelet Count	0	-
White Blood Cell Count	0	-
Urine Glucose	0	-
Urine Ketones	1	-
Urine protein	1	-

Secondary/protocol endpoint

Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population

Time frame:Screening to Week 28

event count, event

componentstotal bilirubin abnormal, glucose abnormal high low, albumin low, creatine kinase high, sodium abnormal high low, potassium abnormal high low, bicarbonate abnormal high low, calcium low

Posted result

Group	Number · Number of Laboratory Values	95% CI
Placeboalanine aminotransferase	0	-
aspartate aminotransferase	0	-
Bicarbonate	0	-
Gamma-glutamyltransferase	17	-
Creatine kinase	18	-
Calcium	2	-
Potassium	0	-
Sodium	2	-
Creatinine	0	-
Total Bilirubin	1	-
Uric Acid	4	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	0	-
Pramlintide 360 mcgalanine aminotransferase	8	-
aspartate aminotransferase	2	-
Bicarbonate	5	-
Gamma-glutamyltransferase	3	-
Creatine kinase	4	-
Calcium	2	-
Potassium	1	-
Sodium	4	-
Creatinine	0	-
Total Bilirubin	0	-
Uric Acid	10	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	0	-
Metreleptin 5.0 mgalanine aminotransferase	1	-
aspartate aminotransferase	0	-
Bicarbonate	1	-
Gamma-glutamyltransferase	5	-
Creatine kinase	4	-
Calcium	2	-
Potassium	0	-
Sodium	2	-
Creatinine	0	-
Total Bilirubin	0	-
Uric Acid	5	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	0	-
Pramlintide 180 mcg + Metreleptin 2.5 mgalanine aminotransferase	0	-
aspartate aminotransferase	0	-
Bicarbonate	5	-
Gamma-glutamyltransferase	1	-
Creatine kinase	9	-
Calcium	7	-
Potassium	1	-
Sodium	4	-
Creatinine	1	-
Total Bilirubin	0	-
Uric Acid	11	-
Alkaline Phosphatase	1	-
Blood urea nitrogen	0	-
Pramlintide 180 mcg + Metreleptin 5.0 mgalanine aminotransferase	0	-
aspartate aminotransferase	1	-
Bicarbonate	1	-
Gamma-glutamyltransferase	13	-
Creatine kinase	8	-
Calcium	1	-
Potassium	2	-
Sodium	2	-
Creatinine	2	-
Total Bilirubin	0	-
Uric Acid	19	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	0	-
Pramlintide 360 mcg + Metreleptin 1.25 mgalanine aminotransferase	0	-
aspartate aminotransferase	0	-
Bicarbonate	0	-
Gamma-glutamyltransferase	0	-
Creatine kinase	4	-
Calcium	0	-
Potassium	1	-
Sodium	0	-
Creatinine	0	-
Total Bilirubin	0	-
Uric Acid	21	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	0	-
Pramlintide 360 mcg + Metreleptin 2.5 mgalanine aminotransferase	0	-
aspartate aminotransferase	0	-
Bicarbonate	0	-
Gamma-glutamyltransferase	0	-
Creatine kinase	2	-
Calcium	13	-
Potassium	2	-
Sodium	3	-
Creatinine	0	-
Total Bilirubin	0	-
Uric Acid	9	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	0	-
Pramlintide 360 mcg + Metreleptin 5.0 mgalanine aminotransferase	3	-
aspartate aminotransferase	2	-
Bicarbonate	1	-
Gamma-glutamyltransferase	6	-
Creatine kinase	2	-
Calcium	0	-
Potassium	6	-
Sodium	0	-
Creatinine	3	-
Total Bilirubin	1	-
Uric Acid	25	-
Alkaline Phosphatase	0	-
Blood urea nitrogen	2	-

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population

Time frame:Baseline to Week 28

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Number · participants	95% CI
Metreleptin 5.0 mg	43	-
Pramlintide 180 mcg + Metreleptin 2.5 mg	49	-
Pramlintide 180 mcg + Metreleptin 5.0 mg	48	-
Pramlintide 360 mcg + Metreleptin 1.25 mg	42	-
Pramlintide 360 mcg + Metreleptin 2.5 mg	50	-
Pramlintide 360 mcg + Metreleptin 5.0 mg	42	-

Secondary/protocol endpoint

Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population

Time frame:Screening to Week 28 (or study termination)

change from baseline, descriptive

Posted result

Group	Mean · msec	95% CI
PlaceboPR Interval	1.1	-
QRS Interval	-0.3	-
QT Interval	0.4	-
QTcF	-0.3	-
Pramlintide 360 mcgPR Interval	-0.1	-
QRS Interval	-1.4	-
QT Interval	9.9	-
QTcF	4.0	-
Metreleptin 5.0 mgPR Interval	0.3	-
QRS Interval	1.0	-
QT Interval	16.2	-
QTcF	8.2	-
Pramlintide 180 mcg + Metreleptin 2.5 mgPR Interval	0.1	-
QRS Interval	-0.5	-
QT Interval	7.0	-
QTcF	-1.2	-
Pramlintide 180 mcg + Metreleptin 5.0 mgPR Interval	16.8	-
QRS Interval	-1.8	-
QT Interval	8.9	-
QTcF	-0.8	-
Pramlintide 360 mcg + Metreleptin 1.25 mgPR Interval	4.4	-
QRS Interval	-0.2	-
QT Interval	4.4	-
QTcF	0.3	-
Pramlintide 360 mcg + Metreleptin 2.5 mgPR Interval	0.4	-
QRS Interval	0.3	-
QT Interval	15.0	-
QTcF	1.3	-
Pramlintide 360 mcg + Metreleptin 5.0 mgPR Interval	-1.6	-
QRS Interval	-0.4	-
QT Interval	6.3	-
QTcF	-2.3	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy.
Clinical endocrinology2016 Jul (month)PMID26589105doi:10.1111/cen.12980via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.