NCT00392925

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

12 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

Study Start

First participant enrolled

October 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed
Last Updated

April 14, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

October 24, 2006

Results QC Date

August 12, 2013

Last Update Submit

March 26, 2015

Conditions

OverweightObesity

Keywords

overweightobesitypramlintideleptinAmylin

Outcome Measures

Primary Outcomes (1)

  • Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population

    Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment.

    Baseline to Week 16

Secondary Outcomes (25)

  • LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population

    Baseline up to Week 20

  • LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population

    Baseline to Week 20

  • LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population

    Enrollment to Week 20

  • LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population

    Enrollment to Week 20

  • Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population

    Baseline to Week 20

  • +20 more secondary outcomes

Study Arms (4)

Placebo and Metreleptin

EXPERIMENTAL

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

Drug: metreleptinDrug: placebo-pramlintide 600 uL

Pramlintide Acetate and Placebo

EXPERIMENTAL

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

Drug: pramlintide acetate 360 mcgDrug: placebo-metreleptin 1 mL

Pramlintide Acetate and Metreleptin

EXPERIMENTAL

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

Drug: pramlintide acetate 360 mcgDrug: metreleptin

Lead-In Period

OTHER

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).

Drug: pramlintide acetate 360 mcgDrug: Pramlintide acetate 180 mcg

Interventions

pramlintide acetate 360 mcgDRUG

subcutaneous injection, twice a day, 360mcg

Also known as: SYMLIN®
Lead-In PeriodPramlintide Acetate and MetreleptinPramlintide Acetate and Placebo
metreleptinDRUG

subcutaneous injection, twice a day, 5mg

Also known as: recombinant-methionyl human leptin
Placebo and MetreleptinPramlintide Acetate and Metreleptin
placebo-pramlintide 600 uLDRUG

twice a day

Placebo and Metreleptin
placebo-metreleptin 1 mLDRUG

twice a day

Pramlintide Acetate and Placebo
Pramlintide acetate 180 mcgDRUG

subcutaneous injection twice a day, 180 mcg

Also known as: SYMLIN®
Lead-In Period

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Is diagnosed with type 2 diabetes
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

DeLand, Florida, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Indianapolis, Indiana, United States

Location

Research Site

Overland Park, Kansas, United States

Location

Research Site

Baton Rouge, Louisiana, United States

Location

Research Site

Detroit, Michigan, United States

Location

Research Site

Edina, Minnesota, United States

Location

Research Site

Butte, Montana, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

Olympia, Washington, United States

Location

Related Publications (1)

  • 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.

    PMID: 26589105DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

pramlintidemetreleptinrecombinant methionyl human leptin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Peter Ohman, Medical Science Director
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Lisa Porter, MD

    Amylin Pharmaceuticals, LLC.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 14, 2015

Results First Posted

February 28, 2014

Record last verified: 2015-03

Locations

US(12)