Phase 2 N=177 Randomized Double-blind Treatment

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

Overweight · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00392925 ↗

Enrolled (actual)

177

Serious AEs

1.7%

Results posted

Feb 2014

Primary outcome: Primary: Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population — -2.68; -3.30; -6.46 kg — p=0.0004

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: pramlintide acetate 360 mcg (Drug); metreleptin (Drug); placebo-pramlintide 600 uL (Drug); placebo-metreleptin 1 mL (Drug); Pramlintide acetate 180 mcg (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Sep 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population	-2.68; -3.30; -6.46	0.0004 sig
SECONDARY LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population	-0.70; -1.55; -2.36; -2.08; -2.74; -4.81	—
SECONDARY LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population	-0.66; -1.43; -2.13; -1.66; -2.32; -4.16	—
SECONDARY LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population	-5.22; -5.93; -6.72; -6.25; -6.85; -8.77	—
SECONDARY LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population	-5.46; -6.20; -7.18; -6.77; -7.33; -9.50	—
SECONDARY Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population	-0.23; -0.25; -0.46; -0.02; -0.05; -0.20	—
SECONDARY 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	5; 13; 22; 6; 14; 25	—
SECONDARY LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population	-4.42; -25.24	—
SECONDARY LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population	-5.49; -6.78; -7.28; -5.74; -7.76; -8.75	—
SECONDARY LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population	-1.08; -2.55; -2.95; -1.29; -3.51; -4.39	—
SECONDARY LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population	-6.36; -8.07; -10.27	—
SECONDARY Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population	14; 30; 27; 9; 11; 11	—
SECONDARY Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population	14; 29; 27; 7; 10; 10	—
SECONDARY Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population	-2.21; -1.86; -3.00; 2.68; -10.76; -20.64	—
SECONDARY Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population	-6.16; -7.98; -7.23; 53.54; -6.56; 18.94	—
SECONDARY Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population	-0.89; -2.18; -3.28; -3.31; -1.60; -2.17	—
SECONDARY Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population	0.00; -1.14; -0.68; -0.61; -0.65; -2.80	—
SECONDARY LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population	-2.8; -4.5; -6.0; 12.14; 11.92; 12.49	—
SECONDARY LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population	-5.5; -3.8; -6.4; -21.8; -19.5; -24.6	—
SECONDARY LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population	-0.7; -0.1; -0.3; -0.7; -0.5; -0.5	—
SECONDARY Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population	-1.2; -3.5; -2.8; 0.9; -3.7; -1.8	—
SECONDARY Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population	-1.3; -0.8; -1.1; 1.3; -0.2; -2.1	—
SECONDARY Number of Chemistry Values of Potential Clinical Importance - Enrolled Population	0; 1; 0; 0; 0; 1	—
SECONDARY Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population	0; 3; 1; 0; 0; 2	—
SECONDARY Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population	19; 3; 39; 19; 0; 37	—

Summary

This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.

Eligibility Criteria

Inclusion Criteria

Is obese (Body Mass Index [BMI]>=30kg/m^2 and =27kg/m^2 and 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00392925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.