GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05804513

UnknownPhase 4

The Effect of Lixisenatide on the Effect of Pituitary Hormones

Lead sponsor

University of Tartu

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Healthy volunteers, Type 1 diabetes

Key I/E criteria

•HbA1c ≤8.5%•Male•Healthy volunteers

Primary endpoint

•Growth hormone area under the curve

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 IDNCT05804513

Org study IDLixi22

Timeline

Milestones

Study first posted2023-04-07actual

Study start2023-04-17actual

Last update posted2023-06-12actual

Primary completion2023-10-31estimated

Study completion2023-12-31estimated

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Healthy volunteersType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

1. Healthy volunteers:

–male sex

–age 18-60 years

–body weight > 65 kg

2. Patients with type 1 diabetes:

–type 1 diabetes

–male sex

–age 18-60 years

–body weight > 65 kg

–c-peptide in fasting blood sample <0,1 nmol/l

–HbA1c < 8,5%

Exclusion criteria

1. Healthy volunteers:

–use of aldosterone antagonist

–use of glucocorticosteroid

–use of other medication that potentially significantly affects pituitary function.

2. Patients with type 1 diabetes:

–use of aldosterone antagonist

–use of glucocorticosteroid

–use of other medication that potentially significantly affects pituitary function.

–The patient is excluded from the study if a significant change in blood glucose occurs in the study center.

Endpoints (12)

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

Other (unclassified)

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Glucose nadir

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

descriptive, improvement

Secondary/protocol endpoint

C-peptide peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

concentration, descriptive

Cardiometabolic biomarkers

2 endpoints

Other/protocol endpoint

Systolic and diastolic blood pressure

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

change from baseline, improvement

Other/protocol endpoint

Heart rate

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration.

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Nausea

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

Nausea

descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Growth hormone area under the curve.

Time frame:0-150 minutes after study drug administration

descriptive

Secondary/protocol endpoint/low confidence

Growth hormone peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration.

concentration, descriptive

Secondary/protocol endpoint/low confidence

Cortisol peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

descriptive

Secondary/protocol endpoint/low confidence

Adrenocorticotropic hormone (ACTH) peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

concentration, descriptive

Secondary/protocol endpoint

Prolactin peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

concentration, descriptive

Secondary/protocol endpoint/low confidence

Copeptin peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

concentration, descriptive

Secondary/protocol endpoint/low confidence

Aldosterone peak

Time frame:30, 60, 90, 120, and 150 minutes after the study drug administration

concentration, descriptive

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.