CompletedPhase 2

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Actual enrollment

184

Study population

Obesity / overweight

Eligibility highlights

•BMI 30-45

Primary endpoint

•Various pharmacodynamic effects of subcutaneously (SC) infused or injected

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00444561

Org study ID137-160

Timeline

Milestones

Study first posted2007-03-08estimated

Last update posted2015-06-11estimated

Study start2004-08 (month precision)

Primary completion2005-05actual (month precision)

Study completion2005-05actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age25 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

Time frame:73 Days

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.