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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Pramlintide acetate 180 mcg; Drug: pramlintide acetate 360 mcg; Drug: metreleptin; Drug: placebo-pramlintide 600 uL; Drug: placebo-metreleptin 1 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00392925

DFA101

Details and patient eligibility

About

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

Enrollment: 177 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 4 patient groups

Placebo and Metreleptin

Experimental group

Description:

Placebo-pramlintide 600 microliters (µL) twice a day (BID) and metreleptin (recombinant-methionyl human leptin) 5 milligram (mg) BID, 20 weeks

Treatment:

Drug: placebo-pramlintide 600 uL

Drug: metreleptin

Pramlintide Acetate and Placebo

Experimental group

Description:

Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and placebo-metreleptin 1 mL BID, 20 weeks

Treatment:

Drug: placebo-metreleptin 1 mL

Drug: pramlintide acetate 360 mcg

Pramlintide Acetate and Metreleptin

Experimental group

Description:

Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and metreleptin (recombinant-methionyl human leptin) 5 mg BID, 20 weeks

Treatment:

Drug: metreleptin

Drug: pramlintide acetate 360 mcg

Lead-In Period

Other group

Description:

During the Lead-In Period before a participant was randomized to a study arm, the participant received 180 mcg pramlintide acetate twice a day (BID) for 2 weeks, followed by 360 mcg pramlintide acetate BID for 2 weeks (total of 4 weeks in the Lead-In Period).

Treatment:

Drug: pramlintide acetate 360 mcg

Drug: Pramlintide acetate 180 mcg