NCT00785408

Brief Summary

A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

18 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

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 19, 2015

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

November 4, 2008

Last Update Submit

January 16, 2015

Conditions

ObesityOverweight

Keywords

obesityoverweightweight lossAmylinAC2307

Outcome Measures

Primary Outcomes (2)

  • To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects

    24 weeks

  • To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects

    24 weeks

Secondary Outcomes (2)

  • To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes

    24 weeks

  • To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects

    24 weeks

Study Arms (6)

1

EXPERIMENTAL
Drug: AC2307

2

EXPERIMENTAL
Drug: AC2307

3

EXPERIMENTAL
Drug: AC2307

4

PLACEBO COMPARATOR
Drug: placebo

5

PLACEBO COMPARATOR
Drug: placebo

6

PLACEBO COMPARATOR
Drug: placebo

Interventions

AC2307DRUG

subcutaneous, twice daily, low dose

1
placeboDRUG

subcutaneous, twice daily, low dose

4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Is obese with a body mass index (BMI) ≥30 kg/m\^2 to ≤45 kg/m\^2, or is overweight with a BMI ≥27 kg/m\^2 to \<30 kg/m\^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)

You may not qualify if:

  • Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
  • Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
  • Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start
  • Has donated blood within 2 months before study start or is planning to donate blood during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Birmingham, Alabama, United States

Location

Research Site

Chandler, Arizona, United States

Location

Research Site

Santa Rosa, California, United States

Location

Research Site

Walnut Creek, California, United States

Location

Research Site

Denver, Colorado, United States

Location

Research Site

Jacksonville, Florida, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Overland Park, Kansas, United States

Location

Research Site

Baton Rouge, Louisiana, United States

Location

Research Site

Butte, Montana, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Eugene, Oregon, United States

Location

Research Site

Medford, Oregon, United States

Location

Research Site

Greer, South Carolina, United States

Location

Research Site

Mt. Pleasant, South Carolina, United States

Location

Research Site

Austin, Texas, United States

Location

Research Site

Olympia, Washington, United States

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

davalintide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Hubert Chen, MD

    Amylin Pharmaceuticals, LLC.

    STUDY DIRECTOR

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

November 4, 2008

First Posted

November 5, 2008

Study Start

December 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 19, 2015

Record last verified: 2014-12

Locations

US(18)