GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

A Phase 2A, Randomized, Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Effect on Body Weight of Recombinant-Methionyl Human Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

177

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-35

Primary endpoint

•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00392925

Org study IDDFA101

Timeline

Milestones

Study first posted2006-10-26estimated

Results first posted2014-02-28estimated

Last update posted2015-04-14estimated

Study start2006-10 (month precision)

Primary completion2007-09actual (month precision)

Study completion2007-09actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight (BMI>=27kg/m^2 and <30kg/m^2) with abdominal obesity, based on the following: *waist circumference >102 cm if male, *waist circumference >88 cm if female

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

•Consumes a morning and evening meal each day

Exclusion criteria

•Is diagnosed with type 2 diabetes

•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 any of the following medications: *antiobesity agents (prescription or over-the-counter), *antipsychotic agents, *antiepileptic agents, *antidepressant agents, *drugs that directly affect gastrointestinal motility

•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 previously received treatment with recombinant leptin or pramlintide

Endpoints (26)

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Patient-reported / QoL

Glycemic / diabetes

Weight & body composition

13 endpoints

Primary/protocol endpoint

Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population

Time frame:Baseline to Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Metreleptin	-2.68	—
Pramlintide Acetate	-3.30	—
Pramlintide Acetate + Metreleptin	-6.46	—

p0.0004ANCOVA

Secondary/protocol endpoint

LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population

Time frame:Baseline up to Week 20

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of change	95% CI
MetreleptinWeek 4 (n=19, 38, 36)	-0.70	—
Week 8 (n=19, 38, 36)	-2.08	—
Week 12 (n=19, 38, 36)	-3.17	—
Week 16 (n=19, 38, 36)	-3.37	—
Week 20 (n=19, 37, 36)	-3.62	—
Pramlintide AcetateWeek 4 (n=19, 38, 36)	-1.55	—
Week 8 (n=19, 38, 36)	-2.74	—
Week 12 (n=19, 38, 36)	-3.39	—
Week 16 (n=19, 38, 36)	-3.85	—
Week 20 (n=19, 37, 36)	-3.89	—
Pramlintide Acetate + MetreleptinWeek 4 (n=19, 38, 36)	-2.36	—
Week 8 (n=19, 38, 36)	-4.81	—
Week 12 (n=19, 38, 36)	-6.13	—
Week 16 (n=19, 38, 36)	-7.59	—
Week 20 (n=19, 37, 36)	-8.21	—

Secondary/protocol endpoint

LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population

Time frame:Baseline to Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
MetreleptinWeek 4 (n=19, 38, 36)	-0.66	—
Week 8 (n=19, 38, 36)	-1.66	—
Week 12 (n=19, 38, 36)	-2.59	—
Week 20 (n=19, 37, 36)	-2.80	—
Pramlintide AcetateWeek 4 (n=19, 38, 36)	-1.43	—
Week 8 (n=19, 38, 36)	-2.32	—
Week 12 (n=19, 38, 36)	-2.97	—
Week 20 (n=19, 37, 36)	-3.30	—
Pramlintide Acetate + MetreleptinWeek 4 (n=19, 38, 36)	-2.13	—
Week 8 (n=19, 38, 36)	-4.16	—
Week 12 (n=19, 38, 36)	-5.28	—
Week 20 (n=19, 37, 36)	-6.90	—

Secondary/protocol endpoint

LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population

Time frame:Enrollment to Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
MetreleptinWeek 4 (n=19, 38, 36)	-5.22	—
Week 8 (n=19, 38, 36)	-6.25	—
Week 12 (n=19, 38, 36)	-7.18	—
Week 16 (n=19, 38, 36)	-7.28	—
Week 20(n=19, 37, 36)	-7.41	—
Pramlintide AcetateWeek 4 (n=19, 38, 36)	-5.93	—
Week 8 (n=19, 38, 36)	-6.85	—
Week 12 (n=19, 38, 36)	-7.50	—
Week 16 (n=19, 38, 36)	-7.84	—
Week 20(n=19, 37, 36)	-7.86	—
Pramlintide + MetreleptinWeek 4 (n=19, 38, 36)	-6.72	—
Week 8 (n=19, 38, 36)	-8.77	—
Week 12 (n=19, 38, 36)	-9.89	—
Week 16 (n=19, 38, 36)	-11.07	—
Week 20(n=19, 37, 36)	-11.52	—

Secondary/protocol endpoint

LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population

Time frame:Enrollment to Week 20

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of change	95% CI
MetreleptinWeek 4 (n=19, 38, 36)	-5.46	—
Week 8 (n=19, 38, 36)	-6.77	—
Week 12 (n=19, 38, 36)	-7.80	—
Week 16 (n=19, 38, 36)	-7.99	—
Week 20 (n=19, 37, 36)	-8.22	—
Pramlintide AcetateWeek 4 (n=19, 38, 36)	-6.20	—
Week 8 (n=19, 38, 36)	-7.33	—
Week 12 (n=19, 38, 36)	-7.95	—
Week 16 (n=19, 38, 36)	-8.37	—
Week 20 (n=19, 37, 36)	-8.42	—
Pramlintide Acetate + MetreleptinWeek 4 (n=19, 38, 36)	-7.18	—
Week 8 (n=19, 38, 36)	-9.50	—
Week 12 (n=19, 38, 36)	-10.75	—
Week 16 (n=19, 38, 36)	-12.13	—
Week 20 (n=19, 37, 36)	-12.72	—

Secondary/protocol endpoint

Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population

Time frame:Baseline to Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/week	95% CI
MetreleptinInitial rate of absolute change	-0.23	—
Late rate of absolute change	-0.02	—
Overall rate of absolute change	-0.16	—
Pramlintide AcetateInitial rate of absolute change	-0.25	—
Late rate of absolute change	-0.05	—
Overall rate of absolute change	-0.17	—
Pramlintide Acetate + MetreleptinInitial rate of absolute change	-0.46	—
Late rate of absolute change	-0.20	—
Overall rate of absolute change	-0.36	—

Secondary/protocol endpoint

Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population

Time frame:Baseline to Weeks 16 and Weeks 20

threshold achievement, improvement

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

Posted result

Group	Value (number), participants	95% CI
MetreleptinWeight Loss of 5% or more Week 16 (n=19, 38, 36)	5	—
Weight Loss of 5% or more Week 20(n=19, 37, 36)	6	—
5% Loss Week 16 Sustained (n=19, 38, 36)	5	—
Weight Loss of 10% or more Week 16(n=19, 38, 36)	1	—
Weight Loss of 10% or more Week 20(n=19, 37, 36)	2	—
10% Loss Week 16 Sustained (n=19, 38, 36)	1	—
Pramlintide AcetateWeight Loss of 5% or more Week 16 (n=19, 38, 36)	13	—
Weight Loss of 5% or more Week 20(n=19, 37, 36)	14	—
5% Loss Week 16 Sustained (n=19, 38, 36)	12	—
Weight Loss of 10% or more Week 16(n=19, 38, 36)	1	—
Weight Loss of 10% or more Week 20(n=19, 37, 36)	2	—
10% Loss Week 16 Sustained (n=19, 38, 36)	1	—
Pramlintide Acetate + MetreleptinWeight Loss of 5% or more Week 16 (n=19, 38, 36)	22	—
Weight Loss of 5% or more Week 20(n=19, 37, 36)	25	—
5% Loss Week 16 Sustained (n=19, 38, 36)	21	—
Weight Loss of 10% or more Week 16(n=19, 38, 36)	9	—
Weight Loss of 10% or more Week 20(n=19, 37, 36)	11	—
10% Loss Week 16 Sustained (n=19, 38, 36)	9	—

Secondary/protocol endpoint

LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population

Time frame:Enrollment to Baseline

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of change	95% CI
Lead-In Participants Randomized to Treatment on Day 1Percent Change in Weight from Enrollment	-4.42	—
Percent Change in Excess Weight from Enrollment	-25.24	—

Secondary/protocol endpoint

LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population

Time frame:Enrollment to Week 20

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
MetreleptinWeek 4 (n=19, 38, 36)	-5.49	—
Week 8 (n=19, 38, 36)	-5.74	—
Week 12 (n=19, 38, 36)	-7.06	—
Week 16 (n=19, 38, 36)	-6.84	—
Week 20 (n=19, 37, 36)	-7.99	—
Pramlintide AcetateWeek 4 (n=19, 38, 36)	-6.78	—
Week 8 (n=19, 38, 36)	-7.76	—
Week 12 (n=19, 38, 36)	-8.46	—
Week 16 (n=19, 38, 36)	-9.00	—
Week 20 (n=19, 37, 36)	-9.17	—
Pramlintide Acetate + MetreleptinWeek 4 (n=19, 38, 36)	-7.28	—
Week 8 (n=19, 38, 36)	-8.75	—
Week 12 (n=19, 38, 36)	-9.88	—
Week 16 (n=19, 38, 36)	-10.66	—
Week 20 (n=19, 37, 36)	-11.61	—

Secondary/protocol endpoint

LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population

Time frame:Baseline to Week 20

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
MetreleptinWeek 4 (n=19, 38, 36)	-1.08	—
Week 8 (n=19, 38, 36)	-1.29	—
Week 12 (n=19, 38, 36)	-2.63	—
Week 16 (n=19, 38, 36)	-2.40	—
Week 20 (n=19, 37, 36)	-3.60	—
Pramlintide AcetateWeek 4 (n=19, 38, 36)	-2.55	—
Week 8 (n=19, 38, 36)	-3.51	—
Week 12 (n=19, 38, 36)	-4.22	—
Week 16 (n=19, 38, 36)	-4.75	—
Week 20 (n=19, 37, 36)	-4.90	—
Pramlintide + MetreleptinWeek 4 (n=19, 38, 36)	-2.95	—
Week 8 (n=19, 38, 36)	-4.39	—
Week 12 (n=19, 38, 36)	-5.54	—
Week 16 (n=19, 38, 36)	-6.30	—
Week 20 (n=19, 37, 36)	-7.28	—

Secondary/protocol endpoint

LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population

Time frame:Screening up to Week 20

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Metreleptin	-6.36	—
Pramlintide Acetate	-8.07	—
Pramlintide Acetate+ Metreleptin	-10.27	—

Secondary/protocol endpoint

Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population

Time frame:Enrollment up to Week 16

BMI, change

categorical status, improvement

Posted result

Group	Value (number), participants	95% CI
MetreleptinObese BMI at Enrollment	14	—
Continued Obese BMI at Week 16	9	—
Decreased BMI to Overweight at Week 16	5	—
Decreased BMI to Normal at Week 16	0	—
Overweight BMI at Enrollment	5	—
Continued Overweight BMI at Week 16	4	—
Decreased BMI to Normal at Week 16	1	—
Pramlintide AcetateObese BMI at Enrollment	30	—
Continued Obese BMI at Week 16	11	—
Decreased BMI to Overweight at Week 16	19	—
Decreased BMI to Normal at Week 16	0	—
Overweight BMI at Enrollment	8	—
Continued Overweight BMI at Week 16	8	—
Decreased BMI to Normal at Week 16	0	—
Pramlintide Acetate + MetreleptinObese BMI at Enrollment	27	—
Continued Obese BMI at Week 16	11	—
Decreased BMI to Overweight at Week 16	16	—
Decreased BMI to Normal at Week 16	0	—
Overweight BMI at Enrollment	9	—
Continued Overweight BMI at Week 16	5	—
Decreased BMI to Normal at Week 16	4	—

Secondary/protocol endpoint

Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population

Time frame:Enrollment up to Week 20

BMI, change

categorical status, improvement

Posted result

Group	Value (number), participants	95% CI
MetreleptinObese BMI at Enrollment	14	—
Continued Obese BMI at Week 20	7	—
Greater Obesity at Week 20	1	—
Decreased BMI to Overweight at Week 20	6	—
Decreased BMI to Normal at Week 20	0	—
Overweight BMI at Enrollment	5	—
Continued Overweight BMI at Week 20	4	—
Decreased BMI to Normal at Week 20	1	—
Pramlintide AcetateObese BMI at Enrollment	29	—
Continued Obese BMI at Week 20	10	—
Greater Obesity at Week 20	0	—
Decreased BMI to Overweight at Week 20	19	—
Decreased BMI to Normal at Week 20	0	—
Overweight BMI at Enrollment	8	—
Continued Overweight BMI at Week 20	8	—
Decreased BMI to Normal at Week 20	0	—
Pramlintide Acetate+ MetreleptinObese BMI at Enrollment	27	—
Continued Obese BMI at Week 20	10	—
Greater Obesity at Week 20	0	—
Decreased BMI to Overweight at Week 20	17	—
Decreased BMI to Normal at Week 20	0	—
Overweight BMI at Enrollment	9	—
Continued Overweight BMI at Week 20	5	—
Decreased BMI to Normal at Week 20	4	—

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population

Time frame:Enrollment to Week 16

change from baseline, improvement

Posted result

Group	Value (mean), µIU/mL	95% CI
MetreleptinBaseline (Day 1) (n=17, 35, 34)	0.00	—
Week 16 (n=18, 34, 35)	-0.61	—
Pramlintide AcetateBaseline (Day 1) (n=17, 35, 34)	-1.14	—
Week 16 (n=18, 34, 35)	-0.65	—
Pramlintide + MetreleptinBaseline (Day 1) (n=17, 35, 34)	-0.68	—
Week 16 (n=18, 34, 35)	-2.80	—

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population

Time frame:Enrollment to Week 16

change from baseline, improvement

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

Posted result

Group	Value (mean), mg/dL	95% CI
MetreleptinGlucose (n=19, 35, 35)	-2.21	—
Total Cholesterol (n=19, 38, 36)	2.68	—
HDL cholesterol (n=19, 38, 36)	1.74	—
LDL cholesterol (n=19, 38, 36)	1.11	—
Triglycerides (n=19, 37, 35)	30.37	—
Pramlintide AcetateGlucose (n=19, 35, 35)	-1.86	—
Total Cholesterol (n=19, 38, 36)	-10.76	—
HDL cholesterol (n=19, 38, 36)	1.63	—
LDL cholesterol (n=19, 38, 36)	-5.50	—
Triglycerides (n=19, 37, 35)	1.57	—
Pramlintide Acetate + MetreleptinGlucose (n=19, 35, 35)	-3.00	—
Total Cholesterol (n=19, 38, 36)	-20.64	—
HDL cholesterol (n=19, 38, 36)	-0.64	—
LDL cholesterol (n=19, 38, 36)	-13.25	—
Triglycerides (n=19, 37, 35)	-9.54	—

Secondary/protocol endpoint

Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population

Time frame:Enrollment to Week 16

Leptin, change

change from baseline, improvement

Posted result

Group	Value (mean), ng/mL	95% CI
MetreleptinBaseline (Day 1) (n=18, 38, 35)	-6.16	—
Week 4 (n=19, 38, 36)	53.54	—
Week 16 (n=19, 38, 36)	375.28	—
Pramlintide AcetateBaseline (Day 1) (n=18, 38, 35)	-7.98	—
Week 4 (n=19, 38, 36)	-6.56	—
Week 16 (n=19, 38, 36)	-3.58	—
Pramlintide Acetate + MetreleptinBaseline (Day 1) (n=18, 38, 35)	-7.23	—
Week 4 (n=19, 38, 36)	18.94	—
Week 16 (n=19, 38, 36)	262.61	—

Secondary/protocol endpoint

Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population

Time frame:Enrollment to Week 16

fasting total amylin

change from baseline, descriptive

Posted result

Group	Value (mean), pM	95% CI
MetreleptinBaseline (Day 1) (n=18, 37, 36)	-0.89	—
Week 16 (n=18, 34, 36)	-3.31	—
Pramlintide AcetateBaseline (Day 1) (n=18, 37, 36)	-2.18	—
Week 16 (n=18, 34, 36)	-1.60	—
Pramlintide Acetate + MetreleptinBaseline (Day 1) (n=18, 37, 36)	-3.28	—
Week 16 (n=18, 34, 36)	-2.17	—

Secondary/protocol endpoint

Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population

Time frame:Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)

change from baseline, improvement

Posted result

Group	Value (mean), mm Hg	95% CI
MetreleptinSystolic BP Change up to Week -2(n=27,56,56,23)	-1.2	—
Diastolic BP Change up to Week -2(n=27,56,56,23)	-3.7	—
Systolic BP Change to Week 16(n=19,39,38)	-6.3	—
Diastolic BP Change to Week 16(n=19,39,38)	-3.7	—
Systolic BP Change to Week 20(n=19,37,38)	-1.2	—
Diastolic BP Change to Week 20(n=19,37,38)	-1.5	—
Pramlintide AcetateSystolic BP Change up to Week -2(n=27,56,56,23)	-3.5	—
Diastolic BP Change up to Week -2(n=27,56,56,23)	-1.8	—
Systolic BP Change to Week 16(n=19,39,38)	-4.5	—
Diastolic BP Change to Week 16(n=19,39,38)	-2.6	—
Systolic BP Change to Week 20(n=19,37,38)	-3.9	—
Diastolic BP Change to Week 20(n=19,37,38)	-1.0	—
Pramlintide Acetate + MetreleptinSystolic BP Change up to Week -2(n=27,56,56,23)	-2.8	—
Diastolic BP Change up to Week -2(n=27,56,56,23)	-1.9	—
Systolic BP Change to Week 16(n=19,39,38)	-1.6	—
Diastolic BP Change to Week 16(n=19,39,38)	0.3	—
Systolic BP Change to Week 20(n=19,37,38)	-1.9	—
Diastolic BP Change to Week 20(n=19,37,38)	1.8	—
Non-Randomized From 4 Week Lead-InSystolic BP Change up to Week -2(n=27,56,56,23)	0.9	—
Diastolic BP Change up to Week -2(n=27,56,56,23)	-0.6	—
Systolic BP Change to Week 16(n=19,39,38)	NA	—
Diastolic BP Change to Week 16(n=19,39,38)	NA	—
Systolic BP Change to Week 20(n=19,37,38)	NA	—
Diastolic BP Change to Week 20(n=19,37,38)	NA	—

Secondary/protocol endpoint

Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population

Time frame:Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/min	95% CI
MetreleptinWeek -2 (n=27,56,56,23)	-1.3	—
Week 16 (n=19, 39, 38)	-0.2	—
Week 20 (n=19, 37, 38)	-0.2	—
Pramlintide AcetateWeek -2 (n=27,56,56,23)	-0.8	—
Week 16 (n=19, 39, 38)	-2.1	—
Week 20 (n=19, 37, 38)	-1.6	—
Pramlintide Acetate + MetreleptinWeek -2 (n=27,56,56,23)	-1.1	—
Week 16 (n=19, 39, 38)	-4.2	—
Week 20 (n=19, 37, 38)	-3.8	—
Non-Randomized From 4 Week Lead-InWeek -2 (n=27,56,56,23)	1.3	—
Week 16 (n=19, 39, 38)	NA	—
Week 20 (n=19, 37, 38)	NA	—

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population

Time frame:Enrollment to Week 16

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
MetreleptinPOMS Total Mood Disturbance Score(n=19, 38, 36)	-2.8	—
IWQOL-Lite Total Score(n=19, 38, 36)	12.14	—
Pramlintide AcetatePOMS Total Mood Disturbance Score(n=19, 38, 36)	-4.5	—
IWQOL-Lite Total Score(n=19, 38, 36)	11.92	—
Pramlintide Acetate + MetreleptinPOMS Total Mood Disturbance Score(n=19, 38, 36)	-6.0	—
IWQOL-Lite Total Score(n=19, 38, 36)	12.49	—

Secondary/protocol endpoint

LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population

Time frame:Enrollment to Week 16

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
MetreleptinBES Total Score (n=17, 36, 34)	-5.5	—
SEQ Food Craving Frequency(n=19, 38, 36)	-21.8	—
SEQ Strength of Food Cravings(n=19, 38, 36)	-16.8	—
SEQ Difficult to Control Eating(n=19, 38, 36)	-23.0	—
SEQ Difficult to Resist Food Cravings(n=19, 38, 36	-22.7	—
SEQ Response to Food Cravings(n=19, 38, 36)	-22.0	—
SEQ Control Portion Sizes(n=19, 38, 36)	-24.8	—
SEQ How Hungry(n=19, 38, 36)	-21.1	—
SEQ How Full After Meal(n=19, 38, 36)	-3.0	—
SEQ Thoughts of Food(n=19, 38, 36)	-20.4	—
SEQ How Pleasant Meals(n=19, 38, 36)	-3.2	—
Pramlintide AcetateBES Total Score (n=17, 36, 34)	-3.8	—
SEQ Food Craving Frequency(n=19, 38, 36)	-19.5	—
SEQ Strength of Food Cravings(n=19, 38, 36)	-11.5	—
SEQ Difficult to Control Eating(n=19, 38, 36)	-20.9	—
SEQ Difficult to Resist Food Cravings(n=19, 38, 36	-18.6	—
SEQ Response to Food Cravings(n=19, 38, 36)	-22.6	—
SEQ Control Portion Sizes(n=19, 38, 36)	-27.5	—
SEQ How Hungry(n=19, 38, 36)	-18.5	—
SEQ How Full After Meal(n=19, 38, 36)	2.8	—
SEQ Thoughts of Food(n=19, 38, 36)	-11.6	—
SEQ How Pleasant Meals(n=19, 38, 36)	-0.8	—
Pramlintide Acetate + MetreleptinBES Total Score (n=17, 36, 34)	-6.4	—
SEQ Food Craving Frequency(n=19, 38, 36)	-24.6	—
SEQ Strength of Food Cravings(n=19, 38, 36)	-19.8	—
SEQ Difficult to Control Eating(n=19, 38, 36)	-29.3	—
SEQ Difficult to Resist Food Cravings(n=19, 38, 36	-30.2	—
SEQ Response to Food Cravings(n=19, 38, 36)	-33.4	—
SEQ Control Portion Sizes(n=19, 38, 36)	-33.1	—
SEQ How Hungry(n=19, 38, 36)	-28.5	—
SEQ How Full After Meal(n=19, 38, 36)	-4.6	—
SEQ Thoughts of Food(n=19, 38, 36)	-21.5	—
SEQ How Pleasant Meals(n=19, 38, 36)	-6.5	—

Secondary/protocol endpoint

LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population

Time frame:Enrollment to Week 16

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
MetreleptinAnxiety Total (n=19, 38, 36)	-0.7	—
Depression Total (n=19, 38, 36)	-0.7	—
Pramlintide AcetateAnxiety Total (n=19, 38, 36)	-0.1	—
Depression Total (n=19, 38, 36)	-0.5	—
Pramlintide Acetate + MetreleptinAnxiety Total (n=19, 38, 36)	-0.3	—
Depression Total (n=19, 38, 36)	-0.5	—

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of Chemistry Values of Potential Clinical Importance - Enrolled Population

Time frame:Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)

descriptive

Posted result

Group	Value (number), laboratory values	95% CI
MetreleptinALT (n=27, 56, 56, 37)	0	—
AST (n=27, 56, 56, 37)	0	—
Bicarbonate (n=27, 55, 56, 37)	3	—
CPK (n=27, 56, 56, 37)	0	—
GGT (n=27, 56, 56, 37)	1	—
Phosphorus (n=27, 56, 56, 37)	0	—
Potassium (n=27, 56, 56, 37)	0	—
Sodium (n=27, 56, 56, 37)	0	—
Total bilirubin (n=27, 56, 56, 37)	0	—
Triglycerides (n=27, 56, 56, 37)	1	—
Uric Acid (n=27, 56, 56, 37)	1	—
Pramlintide AcetateALT (n=27, 56, 56, 37)	1	—
AST (n=27, 56, 56, 37)	1	—
Bicarbonate (n=27, 55, 56, 37)	7	—
CPK (n=27, 56, 56, 37)	1	—
GGT (n=27, 56, 56, 37)	2	—
Phosphorus (n=27, 56, 56, 37)	0	—
Potassium (n=27, 56, 56, 37)	1	—
Sodium (n=27, 56, 56, 37)	1	—
Total bilirubin (n=27, 56, 56, 37)	1	—
Triglycerides (n=27, 56, 56, 37)	0	—
Uric Acid (n=27, 56, 56, 37)	0	—
Pramlintide Acetate + MetreleptinALT (n=27, 56, 56, 37)	0	—
AST (n=27, 56, 56, 37)	0	—
Bicarbonate (n=27, 55, 56, 37)	4	—
CPK (n=27, 56, 56, 37)	6	—
GGT (n=27, 56, 56, 37)	0	—
Phosphorus (n=27, 56, 56, 37)	0	—
Potassium (n=27, 56, 56, 37)	0	—
Sodium (n=27, 56, 56, 37)	0	—
Total bilirubin (n=27, 56, 56, 37)	0	—
Triglycerides (n=27, 56, 56, 37)	0	—
Uric Acid (n=27, 56, 56, 37)	0	—
Non-Randomized From 4 Week Lead-InALT (n=27, 56, 56, 37)	0	—
AST (n=27, 56, 56, 37)	0	—
Bicarbonate (n=27, 55, 56, 37)	0	—
CPK (n=27, 56, 56, 37)	0	—
GGT (n=27, 56, 56, 37)	0	—
Phosphorus (n=27, 56, 56, 37)	1	—
Potassium (n=27, 56, 56, 37)	2	—
Sodium (n=27, 56, 56, 37)	0	—
Total bilirubin (n=27, 56, 56, 37)	0	—
Triglycerides (n=27, 56, 56, 37)	0	—
Uric Acid (n=27, 56, 56, 37)	0	—

Secondary/protocol endpoint

Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population

Time frame:Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)

event count, event

componentsplatelets abnormal, hematocrit low, hemoglobin low, wbc abnormal, urine protein high, urine glucose high, urine ketones high

Posted result

Group	Value (number), participants	95% CI
MetreleptinHematocrit (n=27, 55, 54, 35)	0	—
Hemoglobin (n=27, 56, 54, 36)	0	—
Urine Protein Positive (n=27, 56, 56, 37)	0	—
Pramlintide AcetateHematocrit (n=27, 55, 54, 35)	3	—
Hemoglobin (n=27, 56, 54, 36)	2	—
Urine Protein Positive (n=27, 56, 56, 37)	1	—
Pramlintide Acetate + MetreleptinHematocrit (n=27, 55, 54, 35)	1	—
Hemoglobin (n=27, 56, 54, 36)	1	—
Urine Protein Positive (n=27, 56, 56, 37)	4	—
Non-Randomized From 4 Week Lead-InHematocrit (n=27, 55, 54, 35)	0	—
Hemoglobin (n=27, 56, 54, 36)	0	—
Urine Protein Positive (n=27, 56, 56, 37)	0	—

Secondary/protocol endpoint

Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population

Time frame:Weeks 16, 20, early termination

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
MetreleptinWeek 16 (n=19, 39, 38)	0	—
Week 20 (n=19, 37, 37)	0	—
Early Termination (n=4, 6, 11))	0	—
Pramlintide AcetateWeek 16 (n=19, 39, 38)	0	—
Week 20 (n=19, 37, 37)	0	—
Early Termination (n=4, 6, 11))	0	—
Pramlintide Acetate + MetreleptinWeek 16 (n=19, 39, 38)	0	—
Week 20 (n=19, 37, 37)	0	—
Early Termination (n=4, 6, 11))	0	—

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population

Time frame:Baseline up to Week 16

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
MetreleptinWeek 4 (n=22, 48, 45)	19	—
Week 8 (n=19, 46, 37)	19	—
Week 12 (n=19, 40, 38)	19	—
Week 16 (n=19, 38, 38)	19	—
Pramlintide AcetateWeek 4 (n=22, 48, 45)	3	—
Week 8 (n=19, 46, 37)	0	—
Week 12 (n=19, 40, 38)	0	—
Week 16 (n=19, 38, 38)	1	—
Pramlintide Acetate + MetreleptinWeek 4 (n=22, 48, 45)	39	—
Week 8 (n=19, 46, 37)	37	—
Week 12 (n=19, 40, 38)	38	—
Week 16 (n=19, 38, 38)	38	—

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 1, 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 1, 2026 snapshot.