GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Effects of Pramlintide on Weight Reduction in Clozapine- and Olanzapine-Induced Weight Gain in Obese People Diagnosed With Schizophrenia

Lead sponsor

University of Texas Southwestern Medical Center

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

•BMI ≥27

Primary endpoint

•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 IDNCT00690235

Org study ID092007-025

Timeline

Milestones

Study first posted2008-06-04estimated

Last update posted2018-11-16actual

Results first posted2018-11-16actual

Study start2007-11 (month precision)

Primary completion2011-08actual (month precision)

Study completion2011-08actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Obesity / overweightPsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.

•Volunteers will have a current BMI=>27 but equal to or less than 40.

•Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start.

•Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start.

•Able and willing to give informed consent.

Exclusion criteria

•Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study

–Positive results for infectious diseases and sexually-transmitted diseases will be reported according to the Texas Department of State Health and Texas Administrative Code rules and guidelines

•Any patient with current diabetes mellitus, even if caused by antipsychotic use .

•Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal.

•Any patients with medical disorders that are not properly controlled by medications.

•Pregnant women or women who are breast feeding.

•Patients concomitantly treated with another conventional or second generation antipsychotic medication or with any other anti-obesity drug.

•Mental capacity is limited to the extent that the patient cannot understand the nature of the study along with its risks and benefits.

•Subjects with a high risk of suicide since there is a potential that the study medication will lower the subject's glucose levels.

•Any patient judged by the principal investigator to be inappropriate for the study.

•Known hypersensitivity to study medication or its components

•Non-English speaking

–The clinical assessments that will be used are not available in valid and reliable forms for non-English speaking populations.

Endpoints (1)

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.

Weight & body composition

1 endpoint

Primary/protocol endpoint

Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine

Time frame:16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), pounds	95% CI
Pramlintide	37	—
Placebo	40.5	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.