Clinical trial NCT01235741: A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Keywords: Pramlintide
Metreleptin
Obesity
Amylin
Takeda
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2010-11-07
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population
timeFrame: Day 1 up to Month 6 Follow-Up
measure: Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population
timeFrame: Baseline to Month 6 Follow Up
measure: Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population
timeFrame: Week 1 to Month 6 Follow-Up
measure: Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin
timeFrame: Baseline to Month 6 Follow-Up
measure: Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population
timeFrame: Screening to 6 Month Follow-Up
measure: Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population
timeFrame: Screening to Month 6 Follow-Up
measure: Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population
timeFrame: Baseline to Month 6 Follow-Up
measure: Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population
timeFrame: Baseline up to Month 6 Follow-Up
measure: Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population
timeFrame: Baseline to 6 Month Follow-Up
measure: Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population
timeFrame: Baseline up to Month 6 Follow-Up
measure: Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population
timeFrame: Baseline up to Month 6 Follow-Up
Secondary outcomes:
measure: Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population
timeFrame: Baseline up to Month 6 Follow-Up
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Hyattsville
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Butte
country: United States
facility: Research Site
state: Montana
city: New York
country: United States
facility: Research Site
state: New York
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Arlington
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Senior Vice President, Research & Development
role: STUDY_DIRECTOR
References: