Current partner codePEPTIDESDE
NCT00444561·Phase 2·INTERVENTIONAL

Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects

Status

Completed

Phase

Phase 2

Enrollment

184

Locations

10

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This exploratory study is designed to evaluate various pharmacodynamic effects of subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and postmenopausal female (not on hormone replacement therapy) subjects. The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.

Interventions

Treatment arms and agents.

DRUG

pramlintide acetate

Clear, colorless, sterile solution for SC administration

Timeline

From registration to results.

  1. First posted

    Mar 8, 2007

  2. Study start

    Aug 2004

  3. Primary completion

    May 2005

  4. Study completion

    May 2005

  5. Results posted

    Not reported

  6. Registry updated

    Jun 11, 2015

Outcomes

What the study measures.

Primary outcomes

To evaluate various pharmacodynamic effects (including effects on body weight, food intake, and other parameters) of subcutaneously (SC) infused or injected pramlintide in obese subjects.

Time frame · 73 Days

Secondary outcomes

To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects.

Time frame · 73 Days

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Is \<6'3" (190.5 cm) tall and weighs \<300 lb (\~136.3 kg) * Is obese with a body mass index (BMI) \>=30 kg/m\^2 to \<=45 kg/m\^2 and with a history consistent with progressive weight gain and development of obesity not secondary to drastic or traumatic initiating events (e.g., excessive weight gain due to cessation of smoking) * Is a nonsmoker (never smoked or has not smoked for at least 2 years) * Does not have a clinical diagnosis of diabetes * Has not had a major change in daily physical activity within 2 months prior to study start (e.g., initiation of an exercise program) * Usually consumes three major meals (morning, midday, and evening) each day and rarely (less than once a week) wakes up to eat during the night Exclusion Criteria: * Is currently enrolled in a weight loss program or plans to enroll in a weight loss or exercise program within the next 3 months * Is currently treated or expected to require or undergo treatment or has been treated within 2 months before screening with medications that are excluded: * Over the counter antiobesity agents including herbal supplements or prescription antiobesity agents approved for the long-term (including orlistat \[Xenical\] and sibutramine \[Meridia\]) and the short-term (including phentermine \[Adipex-P, Celltech, Pro-Fast SA, Pro-Fast SR, Fastin, Oby trim, Zantryl, Teramine, Phentride, Phentercot, Obephen, Oby-cap\], mazindol \[Sanorex and Mazanor\], methamphetamine \[Desoxyn\], diethylpropion \[Tenuate and Tenuate Dospan\], phendimetrazine \[Bontril, Prelu-2, Melfiat 105, Unicelles, X-Trozine, Plegine, Adipost, Obezine, Phendiet-105, PT 105\] and benzphetamine \[Didrex\]) treatment of obesity * Systemic steroids by oral, intravenous, or intramuscular route or potent topical steroids that are known to result in high systemic absorption * Alpha- or Beta-Blockers, centrally acting sympathicolytic or sympathicomimetic agents, reserpin, guanethidine, etc. * Psychotropic medications (e.g., tricyclic antidepressants, monoamine oxidase \[MAO\] inhibitors, selective serotonin reuptake inhibitors \[SSRIs\], neuroleptics, lithium, and benzodiazepines) * Hypnotic-sedative medications or medications that may affect sleeping behavior including medications containing caffeine * Drugs that directly affect gastrointestinal motility, including but not limited to: metoclopramide (Reglan®) and cisapride (Propulsid®); and macrolide antibiotics such as erythromycin and newer derivatives * Has received any investigational drug within 3 months before study start * Has participated previously in a study using pramlintide

Study locations

10 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Chula Vista, California, United States

Research Site

Long Beach, California, United States

Research Site

San Diego, California, United States

Research Site

DeLand, Florida, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Lexington, Kentucky, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

New Orleans, Louisiana, United States

Research Site

Butte, Montana, United States

Research Site

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.