ObesityPhase 2NCT00785408
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
A Phase 2 study testing AC2307 in people with Obesity and Overweight, run by AstraZeneca at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- AC2307
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 18 sitesUnited States
- Study dates
- Dec 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Research Site
Austin, Texas
Research Site
Baton Rouge, Louisiana
Research Site
Birmingham, Alabama
Research Site
Butte, Montana
Research Site
Chandler, Arizona
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Denver, Colorado
Research Site
Eugene, Oregon
Research Site
Greer, South Carolina
Research Site
Jacksonville, Florida
Research Site
Medford, Oregon
Research Site
Miami, Florida
Research Site
Mt. Pleasant, South Carolina
Research Site
Olympia, Washington
Research Site
Overland Park, Kansas
Research Site
Santa Rosa, California
Research Site
Walnut Creek, California
About this study
Official title: A Phase 2, 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
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.
- Conditions
- Obesity, Overweight
- Being tested
- AC2307, placebo
- Keywords
- obesity, overweight, weight loss, Amylin, AC2307
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC2307Drug
subcutaneous, twice daily, low dose
placeboDrug
subcutaneous, twice daily, low dose
AC2307Drug
subcutaneous, twice daily, middle dose
placeboDrug
subcutaneous, twice daily, middle dose
AC2307Drug
subcutaneous, twice daily, high dose
placeboDrug
subcutaneous, twice daily, high dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AC2307 |
| 2 | Experimental | Not described Receives: Drug: AC2307 |
| 3 | Experimental | Not described Receives: Drug: AC2307 |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
| 5 | Placebo comparator | Not described Receives: Drug: placebo |
| 6 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
Measured: 24 weeks
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
Measured: 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
Measured: 24 weeks
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert Chen, MD, Study director, Amylin Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785408
- Sponsor's protocol ID
- CFA104
- Status last verified
- Dec 2014
- First submitted
- 4 Nov 2008
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 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
- ClinicalTrials.gov ID
- NCT00785408
- Acronym / sponsor ID
- CFA104
- Conditions
- Obesity, Overweight
- Keywords
- obesity, overweight, weight loss, Amylin, AC2307
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC2307subcutaneous, twice daily, low dose | Drug | 1 |
| placebosubcutaneous, twice daily, low dose | Drug | 4 |
| AC2307subcutaneous, twice daily, middle dose | Drug | 2 |
| placebosubcutaneous, twice daily, middle dose | Drug | 5 |
| AC2307subcutaneous, twice daily, high dose | Drug | 3 |
| placebosubcutaneous, twice daily, high dose | Drug | 6 |
Primary outcome
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
Time frame: 24 weeks
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
Time frame: 24 weeks
2 secondary outcomes
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
Time frame: 24 weeks
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Chen, MD study director
Amylin Pharmaceuticals, LLC.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC2307 in people with Obesity and Overweight, run by AstraZeneca at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.