Clinical trial NCT00392925: A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Official title: A Phase 2A, Randomized, Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Effect on Body Weight of Recombinant-Methionyl Human Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: overweight
obesity
pramlintide
leptin
Amylin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-26
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \<=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

Primary outcomes:
measure: Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population
timeFrame: Baseline up to Week 20
measure: LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population
timeFrame: Baseline to Week 20
measure: LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population
timeFrame: Enrollment to Week 20
measure: LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population
timeFrame: Enrollment to Week 20
measure: Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population
timeFrame: Baseline to Week 20
measure: 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
timeFrame: Baseline to Weeks 16 and Weeks 20
measure: LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population
timeFrame: Enrollment to Baseline
measure: LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population
timeFrame: Enrollment to Week 20
measure: LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population
timeFrame: Baseline to Week 20
measure: LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population
timeFrame: Screening up to Week 20
measure: Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population
timeFrame: Enrollment up to Week 16
measure: Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population
timeFrame: Enrollment up to Week 20
measure: Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population
timeFrame: Enrollment to Week 16
measure: Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population
timeFrame: Enrollment to Week 16
measure: Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population
timeFrame: Enrollment to Week 16
measure: Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population
timeFrame: Enrollment to Week 16
measure: LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population
timeFrame: Enrollment to Week 16
measure: LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population
timeFrame: Enrollment to Week 16
measure: LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population
timeFrame: Enrollment to Week 16
measure: Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population
timeFrame: Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)
measure: Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population
timeFrame: Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)
measure: Number of Chemistry Values of Potential Clinical Importance - Enrolled Population
timeFrame: Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)
measure: Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population
timeFrame: Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)
measure: Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population
timeFrame: Weeks 16, 20, early termination
measure: Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Deland
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Edina
country: United States
facility: Research Site
state: Minnesota
city: Butte
country: United States
facility: Research Site
state: Montana
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Olympia
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References:
citation: Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.