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

NCT00444561 | Completed Phase 2

• 1 other identifier: 137-160
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Overweight; Obesity

Keywords

pramlintide; Symlin; Amylin

Outcome Measures

Primary Outcomes (1)

• 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.

  73 Days

Secondary Outcomes (1)

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

  73 Days

Study Arms (1)

Pramlintide acetate (AC137)

ACTIVE COMPARATOR

Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC administration. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL.

Drug: pramlintide acetate

Interventions

pramlintide acetate DRUG

Clear, colorless, sterile solution for SC administration

Pramlintide acetate (AC137)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Chula Vista, California, United States

Location

Research Site

Long Beach, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

DeLand, Florida, United States

Location

Research Site

Fort Lauderdale, Florida, United States

Location

Research Site

Lexington, Kentucky, United States

Location

Research Site

Baton Rouge, Louisiana, United States

Location

Research Site

New Orleans, Louisiana, United States

Location

Research Site

Butte, Montana, United States

Location

Research Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Porter, MD

  Amylin Pharmaceuticals, LLC.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 8, 2007
• Study Start: August 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: June 11, 2015

Record last verified: 2015-05

Locations

US (10)