DelfaGLP-1 Atlas

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CompletedPhase 2

A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

16

Recruiting sites

—

Enrollment

258

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-50

Primary endpoints

•Treatment-emergent AEs (any)•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00402077
Org study IDAFA203

Timeline

Milestones

Study first posted2006-11-22estimated
Last update posted2015-03-06estimated
Study start2006-11 (month precision)
Primary completion2007-08actual (month precision)
Study completion2007-08actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
•Has been obese or overweight for at least one year prior to study start
•Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin

Exclusion criteria

•Is currently enrolled in or is planning to enroll in a formal weight-loss program
•Is unwilling or unable to participate in a lifestyle intervention program as part of the study
•Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
•Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
•Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
•Has previously used pramlintide either by prescription or as part of a clinical study
•Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
•Has donated blood within 2 months before study start, or is planning to donate blood during the study

Endpoints (9)

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

Weight & body composition
5
Patient-reported / QoL
2
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Absolute change in body weight from baseline to Week 12

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight from baseline to Week 12

Time frame:12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24

Time frame:24 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24

Time frame:24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24

Time frame:24 weeks

Waist circumference, change

change from baseline, improvement

componentsWaist circumference, change

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24

Time frame:24 weeks

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24

Time frame:24 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

All treatment-emergent adverse events occurring during the 24-week treatment period

Time frame:24 weeks

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.