NCT00673387|CompletedPhase 2Results

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

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects.

AstraZeneca ClinicalTrials.gov

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1 other identifier

DFA102

Study Type

interventional

Target

636

Locations

1 country

Sites

Timeline

RegisteredMay 2008

StartedApr 2008

CompletionOct 2009

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

636

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach

1 country

36 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

April 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

November 14, 2013

Completed

Last Updated

April 15, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

May 6, 2008

Results QC Date

August 12, 2013

Last Update Submit

March 26, 2015

Conditions

Overweight Obesity

Keywords

overweightobesitypramlintidemetreleptinAmylin

Outcome Measures

Primary Outcomes (1)

Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population
Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups).
Baseline to Week 28

Secondary Outcomes (26)

Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population
Baseline to Week 28
Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population
Baseline to Week 28
LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population
Baseline to Week 28
LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population
Baseline to Weeks 12 and Week 28
Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide
Week 4 and Week 24
+21 more secondary outcomes

Study Arms (8)

Placebo-P + Placebo-M

PLACEBO COMPARATOR

Placebo matched to pramlintide BID plus placebo matched to metreleptin BID

Drug: placebo-PDrug: placebo-M

Pramlintide 360 mcg + Placebo-M

EXPERIMENTAL

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

Drug: pramlintide acetateDrug: placebo-M

Placebo-P + Metreleptin 5.0 mg

EXPERIMENTAL

Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID

Drug: metreleptinDrug: placebo-P