RecruitingPhase 1

Islet Function in Gestational Diabetes

Lead sponsor

Mayo Clinic

Asset

Avexitide

Intravenous · GLP-1 receptor antagonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Gestational diabetes

Eligibility highlights

•Female

Primary endpoint

•G50

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 IDNCT07806695

Org study ID26-007703

Secondary ID1R01DK148528-01

Timeline

Milestones

Study first posted2026-09-08actual

Last update posted2026-09-08actual

Study start2026-09estimated (month precision)

Primary completion2030-03estimated (month precision)

Study completion2030-12estimated (month precision)

Assets

Investigational agents

Avexitide

Who this study enrolls

Gestational diabetes

Who can enroll

Minimum age20 Years

Maximum age40 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Pregnant individuals with a viable singleton pregnancy who have completed second trimester gestational diabetes screening and are eligible for classification as either gestational diabetes mellitus or no gestational diabetes mellitus.

•Participants must be willing and able to provide informed consent and complete planned pregnancy and postpartum study visits.

Exclusion criteria

•Active systemic illness (e.g. chronic kidney disease, hypertension)

•Pre-pregnancy diabetes mellitus

•Multiple gestation, major fetal anomaly, or non-viable pregnancy on ultrasound

•Fasting glucose ≥ 100 mg/dL or HbA1c ≥ 5.7% in early pregnancy

•One abnormal value on the 3-hour 100 g oral glucose tolerance test

•Glucose at least 190 mg/dL on glucose challenge testing without subsequent 3-hour oral glucose tolerance testing

•Use of medication affecting glucose metabolism before pregnancy or in early pregnancy

•Use of glucose-lowering medication (e.g. metformin, glyburide) other than insulin to treat gestational diabetes mellitus in the current pregnancy

•History of upper gastrointestinal surgery that alters gastric emptying (e.g. bariatric surgery)

•Hemoglobin < than 11 g/dL

Endpoints (4)

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

1 endpoint

Secondary/protocol endpoint

delta insulin secretion rate/delta glucose

Time frame:During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

G50

Time frame:During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

descriptive

Secondary/protocol endpoint/low confidence

Glucagon Secretion Rate

Time frame:During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

descriptive

Secondary/protocol endpoint/low confidence

β-Cell responsivity (Φ)

Time frame:During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.