GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00819234

CompletedPhase 2Results posted

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin in Obese and Overweight Subjects

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

274

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, % change

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 IDNCT00819234

Org study IDDFA102E

Timeline

Milestones

Study first posted2009-01-08estimated

Results first posted2013-12-05estimated

Last update posted2015-04-15estimated

Study start2008-11 (month precision)

Primary completion2009-10actual (month precision)

Study completion2009-11actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations

•Male, or female and meets all the following criteria:

1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)

2. If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study

•Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements

Exclusion criteria

•Is expected to require or undergo treatment with any exclusionary medication.

•Is undesirable as a study participant as judged by the investigator

Endpoints (20)

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

Patient-reported / QoL

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

6 endpoints

Primary/protocol endpoint

LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population

Time frame:Original Study Baseline to Week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of change in weight	95% CI
Placebo - Stable	-2.68	-7.00 – 1.64
Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable	-9.92	-14.30 – -5.53
Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable	-9.24	-13.10 – -5.37
Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable	-8.20	-12.58 – -3.82

LS Mean Difference-7.2395% CI-12.93 – -1.54p0.0135t-test, 2 sided

LS Mean-6.5595% CI-11.89 – -1.21p0.0168t-test, 2 sided

LS Mean-5.5295% CI-11.27 – 0.23p0.0595t-test, 2 sided

Secondary/protocol endpoint

LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population

Time frame:Original baseline to Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Placebo - StableWeek 12 (original study)	-4.59	-6.55 – -2.62
Week 28 (Baseline for Extension)	-3.70	-6.74 – -0.66
Week 36 in Extension Study	-3.53	-6.95 – -0.12
Week 44 in Extension Study	-3.10	-6.82 – 0.63
Week 52 in Extension Study	-2.85	-6.98 – 1.28
Pramlintide 360 Mcg + Metreleptin 1.25 mg - StableWeek 12 (original study)	-6.72	-8.71 – -4.73
Week 28 (Baseline for Extension)	-8.63	-11.72 – -5.55
Week 36 in Extension Study	-9.74	-13.21 – -6.27
Week 44 in Extension Study	-9.38	-13.16 – -5.60
Week 52 in Extension Study	-9.26	-13.45 – -5.07
Pramlintide 360 Mcg + Metreleptin 2.5 mg - StableWeek 12 (original study)	-7.31	-9.07 – -5.55
Week 28 (Baseline for Extension)	-9.91	-12.64 – -7.19
Week 36 in Extension Study	-10.69	-13.75 – -7.63
Week 44 in Extension Study	-10.00	-13.33 – -6.66
Week 52 in Extension Study	-9.65	-13.35 – -5.96
Pramlintide 360 Mcg + Metreleptin 5.0 mg - StableWeek 12 (original study)	-7.06	-9.05 – -5.07
Week 28 (Baseline for Extension)	-9.46	-12.55 – -6.38
Week 36 in Extension Study	-9.21	-12.68 – -5.75
Week 44 in Extension Study	-8.60	-12.38 – -4.82
Week 52 in Extension Study	-7.98	-12.16 – -3.79

Secondary/protocol endpoint

LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population

Time frame:Baseline to Week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
PlaceboWeek 12 (original study)	-4.62	-7.15 – -2.08
Week 28 (baseline in Extension study)	-3.37	-6.63 – -0.10
Week 36 Extension study	-3.24	-6.77 – 0.29
Week 44 Extension study	-3.46	-7.20 – 0.28
Week 52 Extension study	-3.69	-7.43 – 0.05
360 mcg Pramlintide + 1.25mg Metreleptin - StableWeek 12 (original study)	-4.03	-6.57 – -1.49
Week 28 (baseline in Extension study)	-6.48	-9.75 – -3.20
Week 36 Extension study	-8.79	-12.33 – -5.25
Week 44 Extension study	-9.09	-12.74 – -5.44
Week 52 Extension study	-9.08	-12.95 – -5.21
360 mcg Pramlintide + 2.5 Metreleptin - StableWeek 12 (original study)	-5.77	-8.03 – -3.51
Week 28 (baseline in Extension study)	-7.95	-10.92 – -4.97
Week 36 Extension study	-9.19	-12.34 – -6.04
Week 44 Extension study	-9.03	-12.27 – -5.78
Week 52 Extension study	-9.18	-12.52 – -5.84
360 mcg Pramlintide + 5.0 Metreleptin - StableWeek 12 (original study)	-5.70	-8.25 – -3.15
Week 28 (baseline in Extension study)	-8.36	-11.65 – -5.07
Week 36 Extension study	-8.16	-11.71 – -4.60
Week 44 Extension study	-8.76	-12.42 – -5.10
Week 52 Extension study	-7.41	-11.18 – -3.65

Secondary/protocol endpoint

LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population

Time frame:Baseline to Week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of change in weight	95% CI
Placebo - StableWeek 12 of original study	-4.56	-6.48 – -2.65
Week 28 Extension study	-3.78	-6.83 – -0.74
Week 36 Extension study	-3.43	-6.91 – 0.05
Week 44 Extension study	-3.01	-6.86 – 0.84
Week 52 Extension study	-2.68	-7.00 – 1.64
360 mcg Pramlintide + 1.25mg Metreleptin - StableWeek 12 of original study	-6.93	-8.87 – -4.99
Week 28 Extension study	-9.14	-12.22 – -6.05
Week 36 Extension study	-10.27	-13.80 – -6.74
Week 44 Extension study	-9.95	-13.86 – -6.04
Week 52 Extension study	-9.92	-14.30 – -5.53
360 mcg Pramlintide + 2.5 Metreleptin - StableWeek 12 of original study	-7.23	-8.95 – -5.52
Week 28 Extension study	-9.72	-12.44 – -6.99
Week 36 Extension study	-10.43	-13.55 – -7.32
Week 44 Extension study	-9.65	-13.09 – -6.20
Week 52 Extension study	-9.24	-13.10 – -5.37
360 mcg Pramlintide + 5.0 Metreleptin - StableWeek 12 of original study	-7.17	-9.11 – -5.23
Week 28 Extension study	-9.83	-12.91 – -6.74
Week 36 Extension study	-9.51	-13.04 – -5.98
Week 44 Extension study	-8.84	-12.75 – -4.94
Week 52 Extension study	-8.20	-12.58 – -3.82

Secondary/protocol endpoint

Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population

Time frame:Baseline (Day 1) to Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), participants	95% CI
PlaceboWeight Loss >=5% and <10%	3	—
Weight Loss >=10% and <15%	3	—
Weight Loss >=5%	8	—
Weight Loss >=10%	5	—
Weight Loss >=15%	2	—
360 mcg Pramlintide + 1.25mg Metreleptin - StableWeight Loss >=5% and <10%	4	—
Weight Loss >=10% and <15%	2	—
Weight Loss >=5%	12	—
Weight Loss >=10%	8	—
Weight Loss >=15%	6	—
360 mcg Pramlintide + 2.5 Metreleptin - StableWeight Loss >=5% and <10%	10	—
Weight Loss >=10% and <15%	5	—
Weight Loss >=5%	21	—
Weight Loss >=10%	11	—
Weight Loss >=15%	6	—
360 mcg Pramlintide + 5.0 Metreleptin - StableWeight Loss >=5% and <10%	6	—
Weight Loss >=10% and <15%	4	—
Weight Loss >=5%	12	—
Weight Loss >=10%	6	—
Weight Loss >=15%	2	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25Weight Loss >=5% and <10%	6	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	7	—
Weight Loss >=10%	1	—
Weight Loss >=15%	1	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5Weight Loss >=5% and <10%	1	—
Weight Loss >=10% and <15%	1	—
Weight Loss >=5%	3	—
Weight Loss >=10%	2	—
Weight Loss >=15%	1	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0Weight Loss >=5% and <10%	1	—
Weight Loss >=10% and <15%	1	—
Weight Loss >=5%	4	—
Weight Loss >=10%	3	—
Weight Loss >=15%	2	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoWeight Loss >=5% and <10%	6	—
Weight Loss >=10% and <15%	4	—
Weight Loss >=5%	15	—
Weight Loss >=10%	9	—
Weight Loss >=15%	5	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramWeight Loss >=5% and <10%	7	—
Weight Loss >=10% and <15%	6	—
Weight Loss >=5%	18	—
Weight Loss >=10%	11	—
Weight Loss >=15%	5	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramWeight Loss >=5% and <10%	7	—
Weight Loss >=10% and <15%	5	—
Weight Loss >=5%	18	—
Weight Loss >=10%	11	—
Weight Loss >=15%	6	—

Secondary/protocol endpoint

Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population

Time frame:Baseline (Week 28) to Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), participants	95% CI
Placebo - StableWeight Loss >=5% and <10%	2	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	2	—
Weight Loss >=10%	0	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 1.25mg Metreleptin - StableWeight Loss >=5% and <10%	1	—
Weight Loss >=10% and <15%	1	—
Weight Loss >=5%	3	—
Weight Loss >=10%	2	—
Weight Loss >=15%	1	—
360 mcg Pramlintide + 2.5 Metreleptin - StableWeight Loss >=5% and <10%	4	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	4	—
Weight Loss >=10%	0	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 5.0 Metreleptin - StableWeight Loss >=5% and <10%	1	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	1	—
Weight Loss >=10%	0	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25Weight Loss >=5% and <10%	0	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	0	—
Weight Loss >=10%	0	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5Weight Loss >=5% and <10%	0	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	0	—
Weight Loss >=10%	0	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0Weight Loss >=5% and <10%	0	—
Weight Loss >=10% and <15%	2	—
Weight Loss >=5%	2	—
Weight Loss >=10%	2	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoWeight Loss >=5% and <10%	7	—
Weight Loss >=10% and <15%	1	—
Weight Loss >=5%	8	—
Weight Loss >=10%	1	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramWeight Loss >=5% and <10%	3	—
Weight Loss >=10% and <15%	0	—
Weight Loss >=5%	3	—
Weight Loss >=10%	0	—
Weight Loss >=15%	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramWeight Loss >=5% and <10%	3	—
Weight Loss >=10% and <15%	2	—
Weight Loss >=5%	5	—
Weight Loss >=10%	2	—
Weight Loss >=15%	0	—

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population

Time frame:Baseline to Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), µIU/mL	95% CI
Placebo - Stable	-0.54	-2.97 – 1.89
360 mcg Pramlintide + 1.25mg Metreleptin - Stable	-2.16	-4.71 – 0.39
360 mcg Pramlintide + 2.5 Metreleptin - Stable	-0.62	-2.94 – 1.70
360 mcg Pramlintide + 5.0 Metreleptin - Stable	-1.61	-4.20 – 0.97

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population

Time frame:Original Study Baseline to Extension Week 52 and follow up

Leptin, change

change from baseline, improvement

Posted result

Group	Value (geometric_mean), ng/mL	95% CI
Pramlintide 360 Mcg + Metreleptin 1.25 mg - StableDFA102 Baseline	32.50	—
DFA102E Baseline (Week 28)	102.02	—
Week 40	96.23	—
Week 52	88.47	—
Follow up post treatment	52.90	—
Pramlintide 360 Mcg + Metreleptin 2.5 mg - StableDFA102 Baseline	34.48	—
DFA102E Baseline (Week 28)	232.48	—
Week 40	236.02	—
Week 52	177.32	—
Follow up post treatment	89.21	—
Pramlintide 360 Mcg + Metreleptin 5.0 mg - StableDFA102 Baseline	29.50	—
DFA102E Baseline (Week 28)	420.24	—
Week 40	416.52	—
Week 52	259.85	—
Follow up post treatment	89.49	—

Secondary/protocol endpoint

LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population

Time frame:Baseline (Day 1) to Week 52

change from baseline, improvement

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

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Placebo - Stableglucose	-1.88	-5.62 – 1.85
total cholesterol	4.19	-8.25 – 16.63
triglycerides	-10.05	-26.77 – 6.67
low density lipoprotein (LDL)	13.43	1.96 – 24.90
high density lipoprotein (HDL)	2.92	-0.36 – 6.21
360 mcg Pramlintide + 1.25mg Metreleptin - Stableglucose	-0.60	-4.36 – 3.17
total cholesterol	-2.21	-15.10 – 10.68
triglycerides	-5.41	-22.58 – 11.76
low density lipoprotein (LDL)	4.43	-7.49 – 16.35
high density lipoprotein (HDL)	7.96	4.57 – 11.36
360 mcg Pramlintide + 2.5 Metreleptin - Stableglucose	0.03	-3.38 – 3.43
total cholesterol	-3.24	-14.84 – 8.35
triglycerides	-5.86	-21.16 – 9.43
low density lipoprotein (LDL)	6.03	-4.64 – 16.70
high density lipoprotein (HDL)	5.04	2.01 – 8.08
360 mcg Pramlintide + 5.0 Metreleptin - Stableglucose	-6.29	-10.07 – -2.50
total cholesterol	-3.84	-17.12 – 9.43
triglycerides	-12.74	-30.12 – 4.64
low density lipoprotein (LDL)	4.43	-7.97 – 16.82
high density lipoprotein (HDL)	7.61	4.10 – 11.12

Secondary/protocol endpoint

Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population

Time frame:Baseline to end of treatment follow up

Leptin, change

change from baseline, improvement

Posted result

Group	Value (geometric_mean), ng/mL	95% CI
Pramlintide 360 Mcg + Metreleptin 1.25 mg - StableBaseline in DFA102 (Day 1)	32.50	—
Baseline in DFA102E (Week 28)	102.02	—
Week 40	96.23	—
Week 52	88.47	—
Follow up after end of treatment	52.90	—
Pramlintide 360 Mcg + Metreleptin 2.5 mg - StableBaseline in DFA102 (Day 1)	34.48	—
Baseline in DFA102E (Week 28)	232.48	—
Week 40	236.02	—
Week 52	177.32	—
Follow up after end of treatment	89.21	—
Pramlintide 360 Mcg + Metreleptin 5 mg - StableBaseline in DFA102 (Day 1)	29.50	—
Baseline in DFA102E (Week 28)	420.24	—
Week 40	416.52	—
Week 52	259.85	—
Follow up after end of treatment	89.49	—

Secondary/protocol endpoint

Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population

Time frame:Baseline (Day 1) to Week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mm Hg	95% CI
Placebo - StableSystolic Blood Pressure	-1.0	—
Diastolic Blood Pressure	-0.6	—
360 mcg Pramlintide + 1.25mg Metreleptin - StableSystolic Blood Pressure	1.8	—
Diastolic Blood Pressure	-0.6	—
360 mcg Pramlintide + 2.5 Metreleptin - StableSystolic Blood Pressure	-4.6	—
Diastolic Blood Pressure	-2.7	—
360 mcg Pramlintide + 5.0 Metreleptin - StableSystolic Blood Pressure	-4.9	—
Diastolic Blood Pressure	-1.5	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25Systolic Blood Pressure	0.7	—
Diastolic Blood Pressure	-1.7	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5Systolic Blood Pressure	3.7	—
Diastolic Blood Pressure	-0.3	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0Systolic Blood Pressure	-6.4	—
Diastolic Blood Pressure	-5.3	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoSystolic Blood Pressure	-2.9	—
Diastolic Blood Pressure	-5.8	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramSystolic Blood Pressure	-7.0	—
Diastolic Blood Pressure	-2.5	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramSystolic Blood Pressure	-4.8	—
Diastolic Blood Pressure	-4.0	—

Secondary/protocol endpoint

Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population

Time frame:Baseline to Week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), bpm	95% CI
Placebo - Stable	-3.1	—
360 mcg Pramlintide + 1.25mg Metreleptin - Stable	-1.8	—
360 mcg Pramlintide + 2.5 Metreleptin - Stable	-3.1	—
360 mcg Pramlintide + 5.0 Metreleptin - Stable	-1.4	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25	-1.6	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5	0.9	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0	-0.9	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono	-2.6	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram	-4.0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram	-2.8	—

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population

Time frame:Screening to Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Placebo - StableFrequency of Food Cravings	-14.1	—
Strength of Food Cravings	-14.3	—
Difficult to Control Eating	-18.3	—
Difficult to Resist Food Cravings	-17.6	—
Eating in Response to Food Cravings	-18.4	—
Difficult to Control Portion Sizes	-24.6	—
How Hungry	-1.2	—
How Full After Meals	-6.5	—
Thoughts of Food	-8.5	—
How Pleasant Meals	-1.0	—
360 mcg Pramlintide + 1.25mg Metreleptin - StableFrequency of Food Cravings	-14.4	—
Strength of Food Cravings	-13.3	—
Difficult to Control Eating	-19.7	—
Difficult to Resist Food Cravings	-20.0	—
Eating in Response to Food Cravings	-18.7	—
Difficult to Control Portion Sizes	-19.9	—
How Hungry	-12.8	—
How Full After Meals	-10.1	—
Thoughts of Food	-12.3	—
How Pleasant Meals	-2.8	—
360 mcg Pramlintide + 2.5 Metreleptin - StableFrequency of Food Cravings	-15.0	—
Strength of Food Cravings	-14.2	—
Difficult to Control Eating	-23.3	—
Difficult to Resist Food Cravings	-24.2	—
Eating in Response to Food Cravings	-20.4	—
Difficult to Control Portion Sizes	-25.0	—
How Hungry	-20.3	—
How Full After Meals	-1.9	—
Thoughts of Food	-17.9	—
How Pleasant Meals	8.4	—
360 mcg Pramlintide + 5.0 Metreleptin - StableFrequency of Food Cravings	-21.4	—
Strength of Food Cravings	-17.9	—
Difficult to Control Eating	-17.6	—
Difficult to Resist Food Cravings	-16.9	—
Eating in Response to Food Cravings	-21.3	—
Difficult to Control Portion Sizes	-31.7	—
How Hungry	-12.9	—
How Full After Meals	3.5	—
Thoughts of Food	-17.4	—
How Pleasant Meals	15.5	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25Frequency of Food Cravings	-3.1	—
Strength of Food Cravings	5.3	—
Difficult to Control Eating	-8.8	—
Difficult to Resist Food Cravings	-3.0	—
Eating in Response to Food Cravings	-1.8	—
Difficult to Control Portion Sizes	-6.6	—
How Hungry	0.1	—
How Full After Meals	0.8	—
Thoughts of Food	-1.5	—
How Pleasant Meals	8.8	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5Frequency of Food Cravings	-22.6	—
Strength of Food Cravings	-30.3	—
Difficult to Control Eating	-31.6	—
Difficult to Resist Food Cravings	-30.9	—
Eating in Response to Food Cravings	-26.6	—
Difficult to Control Portion Sizes	-24.4	—
How Hungry	-17.9	—
How Full After Meals	-4.3	—
Thoughts of Food	-26.3	—
How Pleasant Meals	8.4	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0Frequency of Food Cravings	-13.7	—
Strength of Food Cravings	-9.5	—
Difficult to Control Eating	-17.7	—
Difficult to Resist Food Cravings	-15.7	—
Eating in Response to Food Cravings	-7.3	—
Difficult to Control Portion Sizes	-11.5	—
How Hungry	-5.0	—
How Full After Meals	11.8	—
Thoughts of Food	-14.5	—
How Pleasant Meals	7.7	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoFrequency of Food Cravings	-18.9	—
Strength of Food Cravings	-13.0	—
Difficult to Control Eating	-22.1	—
Difficult to Resist Food Cravings	-25.6	—
Eating in Response to Food Cravings	-27.4	—
Difficult to Control Portion Sizes	-33.1	—
How Hungry	-20.8	—
How Full After Meals	-6.2	—
Thoughts of Food	-16.3	—
How Pleasant Meals	7.1	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramFrequency of Food Cravings	-12.8	—
Strength of Food Cravings	-8.8	—
Difficult to Control Eating	-16.6	—
Difficult to Resist Food Cravings	-18.5	—
Eating in Response to Food Cravings	-13.4	—
Difficult to Control Portion Sizes	-24.4	—
How Hungry	-8.2	—
How Full After Meals	-1.3	—
Thoughts of Food	-6.0	—
How Pleasant Meals	1.3	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramFrequency of Food Cravings	-21.4	—
Strength of Food Cravings	-14.6	—
Difficult to Control Eating	-28.7	—
Difficult to Resist Food Cravings	-25.8	—
Eating in Response to Food Cravings	-29.2	—
Difficult to Control Portion Sizes	-27.4	—
How Hungry	-16.2	—
How Full After Meals	-10.2	—
Thoughts of Food	-18.4	—
How Pleasant Meals	-5.2	—

Secondary/protocol endpoint

Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population

Time frame:Screening to Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Placebo - Stable	-5.8	—
360 mcg Pramlintide + 1.25mg Metreleptin - Stable	-5.7	—
360 mcg Pramlintide + 2.5 Metreleptin - Stable	-7.1	—
360 mcg Pramlintide + 5.0 Metreleptin - Stable	-7.4	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25	-0.3	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5	-10.4	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0	-8.6	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono	-8.1	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram	-5.3	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram	-8.1	—

Secondary/protocol endpoint

Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores - Week 52 Evaluable Population

Time frame:Screening to Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Placebo - StableChange in Total Scores for Anxiety	-0.4	—
Change in Total Scores for Depression	-1.0	—
360 mcg Pramlintide + 1.25mg Metreleptin - StableChange in Total Scores for Anxiety	-1.2	—
Change in Total Scores for Depression	-2.1	—
360 mcg Pramlintide + 2.5 Metreleptin - StableChange in Total Scores for Anxiety	-0.5	—
Change in Total Scores for Depression	-0.9	—
360 mcg Pramlintide + 5.0 Metreleptin - StableChange in Total Scores for Anxiety	-0.2	—
Change in Total Scores for Depression	-0.3	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25Change in Total Scores for Anxiety	-0.8	—
Change in Total Scores for Depression	0.3	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5Change in Total Scores for Anxiety	0.1	—
Change in Total Scores for Depression	-1.0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0Change in Total Scores for Anxiety	0.4	—
Change in Total Scores for Depression	-0.8	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoChange in Total Scores for Anxiety	-0.7	—
Change in Total Scores for Depression	-1.3	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramChange in Total Scores for Anxiety	-1.2	—
Change in Total Scores for Depression	-0.9	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramChange in Total Scores for Anxiety	-0.8	—
Change in Total Scores for Depression	-1.7	—

Secondary/protocol endpoint

Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - Week 52 Evaluable Population

Time frame:Screening to Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Placebo - Stable	-2.0	—
360 mcg Pramlintide + 1.25mg Metreleptin - Stable	-2.5	—
360 mcg Pramlintide + 2.5 Metreleptin - Stable	-2.5	—
360 mcg Pramlintide + 5.0 Metreleptin - Stable	-1.3	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25	0.2	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5	-3.9	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0	0.0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono	-1.3	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram	-1.2	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram	-1.1	—

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population

Time frame:Screening to Week 52

change from baseline, descriptive

Posted result

Group	Value (mean), msec	95% CI
Placebo - StablePR Interval	1.2	—
QRS	-0.2	—
QT Interval	15.3	—
QTcF	1.3	—
360 mcg Pramlintide + 1.25mg Metreleptin - StablePR Interval	1.2	—
QRS	3.4	—
QT Interval	8.1	—
QTcF	0.3	—
360 mcg Pramlintide + 2.5 Metreleptin - StablePR Interval	3.6	—
QRS	1.8	—
QT Interval	15.6	—
QTcF	1.4	—
360 mcg Pramlintide + 5.0 Metreleptin - StablePR Interval	0.6	—
QRS	1.0	—
QT Interval	8.2	—
QTcF	-2.2	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25PR Interval	15.8	—
QRS	-2.4	—
QT Interval	19.4	—
QTcF	7.1	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5PR Interval	6.0	—
QRS	1.6	—
QT Interval	13.3	—
QTcF	5.1	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0PR Interval	2.5	—
QRS	0.0	—
QT Interval	2.5	—
QTcF	6.5	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoPR Interval	-2.3	—
QRS	1.7	—
QT Interval	14.4	—
QTcF	3.2	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramPR Interval	1.8	—
QRS	0.5	—
QT Interval	5.5	—
QTcF	-1.7	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramPR Interval	0.9	—
QRS	-0.9	—
QT Interval	16.7	—
QTcF	0.8	—

Secondary/protocol endpoint

Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population

Time frame:Baseline to Week 52

event count, event

Posted result

Group	Value (number), number of laboratory values	95% CI
Placebo - StableHematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 1.25mg Metreleptin - StableHematocrit	0	—
Hemoglobin	1	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 2.5 Metreleptin - StableHematocrit	4	—
Hemoglobin	4	—
Platelet Count	3	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 5.0 Metreleptin - StableHematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25Hematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5Hematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0Hematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre MonoHematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower PramHematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower PramHematocrit	0	—
Hemoglobin	0	—
Platelet Count	0	—
WBC	0	—
Urinalysis	0	—

Secondary/protocol endpoint

Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population

Time frame:Baseline to Week 52

event count, event

Posted result

Group	Value (number), Number of Laboratory values	95% CI
Placebo - Stablealanine aminotransferase (ALT)	0	—
Bicarbonate	0	—
Creatine kinase	1	—
Calcium	0	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	0	—
Uric Acid	0	—
360 mcg Pramlintide + 1.25mg Metreleptin - Stablealanine aminotransferase (ALT)	0	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	0	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	0	—
Uric Acid	0	—
360 mcg Pramlintide + 2.5 Metreleptin - Stablealanine aminotransferase (ALT)	0	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	1	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	1	—
Sodium	1	—
Uric Acid	1	—
360 mcg Pramlintide + 5.0 Metreleptin - Stablealanine aminotransferase (ALT)	1	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	0	—
Creatinine	1	—
Gamma-glutamyltransferase	3	—
Potassium	2	—
Sodium	0	—
Uric Acid	2	—
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25alanine aminotransferase (ALT)	0	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	1	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	1	—
Uric Acid	0	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5alanine aminotransferase (ALT)	0	—
Bicarbonate	1	—
Creatine kinase	0	—
Calcium	0	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	0	—
Uric Acid	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0alanine aminotransferase (ALT)	1	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	1	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	0	—
Uric Acid	0	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Monoalanine aminotransferase (ALT)	0	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	0	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	0	—
Uric Acid	1	—
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pramalanine aminotransferase (ALT)	0	—
Bicarbonate	1	—
Creatine kinase	2	—
Calcium	2	—
Creatinine	0	—
Gamma-glutamyltransferase	0	—
Potassium	0	—
Sodium	0	—
Uric Acid	3	—
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pramalanine aminotransferase (ALT)	0	—
Bicarbonate	0	—
Creatine kinase	0	—
Calcium	0	—
Creatinine	0	—
Gamma-glutamyltransferase	1	—
Potassium	0	—
Sodium	0	—
Uric Acid	2	—

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population

Time frame:Baseline to end of treatment follow up

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
360 mcg Pramlintide + Metreleptin 1.25 mg - StableWeek 52	20	—
Follow up after end of treatment	17	—
360 mcg Pramlintide + Metreleptin 2.5 mg - StableWeek 52	58	—
Follow up after end of treatment	57	—
360 mcg Pramlintide + Metreleptin 5 mg - StableWeek 52	71	—
Follow up after end of treatment	68	—
360 mcg Pramlintide + Metreleptin 1.25 mg - Prior MonotherapyWeek 52	8	—
Follow up after end of treatment	8	—
360 mcg Pramlintide + Metreleptin 2.5 mg - Prior MonotherapyWeek 52	7	—
Follow up after end of treatment	7	—
360 mcg Pramlintide + Metreleptin 5 mg - Prior MonotherapyWeek 52	7	—
Follow up after end of treatment	7	—

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.