Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: pramlintide acetate; Drug: placebo-P; Drug: metreleptin; Drug: placebo-M

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673387

DFA102

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.

Enrollment: 636 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 years old.
• Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight (BMI>=27kg/m^2 and <30kg/m^2.
• Has stable body weight, i.e., not varying by >3% within 3 months prior to study.
• Has not been treated over the past 3 months or is currently treated with any of the following medications: Oral contraceptives (female subjects); Hormone replacement therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement therapy; selective serotonin reuptake inhibitors (SSRIs).
• Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study.
• Is a nonsmoker (has not smoked for at least 6 months prior to the study).

Exclusion criteria

• Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics suggestive of genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet-Biedl syndrome).
• 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 *antiobesity agents (prescription or over-the-counter), *antipsychotic agents, *antiepileptic agents, *antidepressant agents, *drugs that directly affect gastrointestinal motility, *antidiabetic medications.
• Has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®).
• 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 had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study.
• Has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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636 participants in 8 patient groups, including a placebo group

Placebo-P + Placebo-M

Placebo Comparator group

Description:

Placebo matched to pramlintide BID plus placebo matched to metreleptin BID

Treatment:

Drug: placebo-M

Drug: placebo-P

Pramlintide 360 mcg + Placebo-M

Experimental group

Description:

360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID

Treatment:

Drug: placebo-M

Drug: pramlintide acetate

Placebo-P + Metreleptin 5.0 mg

Experimental group

Description:

Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID

Treatment:

Drug: metreleptin

Drug: placebo-P

Pramlintide 180 mcg + Metreleptin 2.5 mg

Experimental group

Description:

Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID

Treatment:

Drug: metreleptin

Drug: pramlintide acetate

Pramlintide 180 mcg + Metreleptin 5.0 mg

Experimental group

Description:

Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID

Treatment:

Drug: metreleptin

Drug: pramlintide acetate

Pramlintide 360 mcg + Metreleptin 1.25 mg

Experimental group

Description:

Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID

Treatment:

Drug: metreleptin

Drug: pramlintide acetate

Pramlintide 360 mcg + Metreleptin 2.5 mg

Experimental group

Description:

Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID

Treatment:

Drug: metreleptin

Drug: pramlintide acetate

Pramlintide 360 mcg + Metreleptin 5.0 mg

Experimental group

Description:

Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID

Treatment:

Drug: metreleptin

Drug: pramlintide acetate