CompletedPhase 1

Exendin(9-39)Amide as a Glucagon-like Peptide-1 (GLP-1) Receptor Antagonist in Humans

Effect of GLP-1 on Glucose Metabolism in Healthy Subjects and Patients With T2DM. Part 1: A Pilot Study to Assess the Efficacy of Exendin(9-39)Amide as a GLP-1 Receptor Antagonist in Healthy Subjects

Lead sponsor

Ludwig-Maximilians - University of Munich

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

•BMI ≤30•HbA1c ≤6%•Healthy volunteers

Primary endpoint

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 IDNCT00393445

Org study IDDOF-Ex

Secondary IDDFG Schi 527/1-2

Timeline

Milestones

Study first posted2006-10-27estimated

Last update posted2011-10-04estimated

Study start2006-11 (month precision)

Study completion2007-05actual (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy volunteers

•Age 18-65 years

•Hemoglobin A1c (HbA1c) < 6%

•Body mass index (BMI) < 30 kg/m2

•Must have a fasting blood glucose below 100 mg/dl at screening and on all study days

•Able to provide written informed consent prior to study participation

•Able to communicate well with the investigator and comply with the requirements of the study

Exclusion criteria

•Diabetes mellitus

•Fasting triglycerides > 5.1 mmol/L (> 450 mg/dL) within the past 4 weeks.

•Treatment with systemic steroids and thyroid hormone

•Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.

•Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.

•Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.

•Significant illness within the two weeks prior to dosing.

•Past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.

•History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.

•Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following:

-history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding

-history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection

-history or clinical evidence of pancreatic injury or pancreatitis

-history or presence of impaired renal function as indicated by abnormal creatinine or urea values or abnormal urinary constituents (e.g., albuminuria)

-evidence of urinary obstruction or difficulty in voiding at screening

•Polymorphonuclears < 1500/µL at inclusion or platelet count < 100,000/μL at screening and baseline.

•Evidence of liver disease as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin.

•History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.

Endpoints (0)

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.

No endpoints recorded for this trial.

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.