TerminatedPhase 2Results posted

A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

A Randomized, Double-Blind, Placebo-Controled, Multicenter Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects Following A Low-Calorie Diet Lead-In

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Actual enrollment

213

Study population

Obesity / overweight

Eligibility highlights

•BMI 35-45

Primary endpoints

•Treatment-emergent AEs (any)•Leptin, change•Immunogenicity (ADA)

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 IDNCT01235741

Org study IDDFA104

Timeline

Milestones

Study first posted2010-11-08estimated

Results first posted2013-12-09estimated

Last update posted2015-04-15estimated

Study start2011-01 (month precision)

Primary completion2011-09actual (month precision)

Study completion2011-09actual (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

•Is obese with a BMI ≥35 to ≤45 kg/m2.

•Has stable body weight (not varying by >5% within 3 months prior to study start).

•Meets certain requirements with respect to concomitant medications.

•Has not smoked or used nicotine-containing products for at least 12 months prior to study start.

Exclusion criteria

•Has not been enrolled in a weight loss program within 2 months prior to study start.

Endpoints (12)

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

Safety / tolerability / PK

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population

Time frame:Baseline up to Month 6 Follow-Up

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage of change in weight	95% CI
PlaceboWeek 1	-0.34	-
6 Month Follow-Up	-0.02	-
Pramlintide + MetreleptinWeek 1	-0.26	-
6 Month Follow-Up	-1.80	-

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population

Time frame:Baseline to 6 Month Follow-Up

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Mean · mg/dL	95% CI
Placebo	6.8	-
Pramlintide + Metreleptin	-1.0	-

Primary/protocol endpoint

Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population

Time frame:Baseline up to Month 6 Follow-Up

change from baseline, improvement

Posted result

Group	Mean · mU/L	95% CI
Placebo	3.41	-
Pramlintide + Metreleptin	3.46	-

Cardiometabolic biomarkers

4 endpoints

Primary/protocol endpoint

Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population

Time frame:Baseline to Month 6 Follow Up

Leptin, change

change from baseline, improvement

Posted result

Group	Mean · ng/mL	95% CI
Pramlintide + MetreleptinChange from baseline to Week 2 of treatment	223.38	-
Change from baseline to Month 2 Follow up	15.46	-
Change from baseline to Month 4 Follow up	20.08	-
Month 6 Follow up	10.70	-

Primary/protocol endpoint

Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population

Time frame:Baseline to Month 6 Follow-Up

change from baseline, improvement

Posted result

Group	Mean · mmHg	95% CI
PlaceboSystolic Blood Pressure	4.3	-
Diastolic Blood Pressure	2.7	-
Pramlintide + MetreleptinSystolic Blood Pressure	3.1	-
Diastolic Blood Pressure	2.7	-

Primary/protocol endpoint

Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population

Time frame:Baseline up to Month 6 Follow-Up

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · beats/min	95% CI
Placebo	1.2	-
Pramlintide + Metreleptin	1.2	-

Primary/protocol endpoint

Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population

Time frame:Baseline up to Month 6 Follow-Up

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
PlaceboTotal Cholesterol	21.7	-
HDL cholesterol	7.7	-
LDL cholesterol	14.0	-
Triglycerides	10.4	-
Pramlintide + MetreleptinTotal Cholesterol	14.7	-
HDL cholesterol	6.6	-
LDL cholesterol	9.6	-
Triglycerides	3.0	-

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population

Time frame:Day 1 up to Month 6 Follow-Up

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Number · participants	95% CI
On Treatment Placebo	6	-
On Treatment Pramlintide + Metreleptin	13	-
Post Treatment Placebo Arm	13	-
Post Treatment Pramlintide + Metreleptin Arm	16	-

Primary/protocol endpoint

Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population

Time frame:Week 1 to Month 6 Follow-Up

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Number · participants	95% CI
Pramlintide + MetreleptinWeek 1	0	-
Week 2	1	-
Early Termination	9	-
Month 2 Follow-Up	15	-
Month 4 Follow-Up	10	-
Month 6 Follow-Up	8	-

Primary/protocol endpoint

Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin

Time frame:Baseline to Month 6 Follow-Up

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Number · participants	95% CI
Pramlintide + Metreleptin	0	-

Primary/protocol endpoint

Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population

Time frame:Screening to 6 Month Follow-Up

threshold achievement, event

Posted result

Group	Number · participants	95% CI
PlaceboHematocrit	0	-
Hemoglobin	0	-
Glucose in Urine	0	-
Pramlintide + MetreleptinHematocrit	1	-
Hemoglobin	1	-
Glucose in Urine	1	-

Primary/protocol endpoint

Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population

Time frame:Screening to Month 6 Follow-Up

threshold achievement, event

componentstotal bilirubin high, glucose high or low, albumin low, creatine kinase high, sodium high or low, potassium high or low, bicarbonate high or low, calcium high or low, triglycerides high, cholesterol high or low, alkaline phosphatase high

Posted result

Group	Number · participants	95% CI
PlaceboCreatine Kinase	2	-
Urate	0	-
Bilirubin	0	-
Pramlintide + MetreleptinCreatine Kinase	3	-
Urate	2	-
Bilirubin	1	-

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.