WithdrawnPhase 2

Mechanisms Underlying Predictors of Success From Obesity Surgery

Lead sponsor

Icahn School of Medicine at Mount Sinai

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥35

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 IDNCT02697253

Org study IDGCO 15-1990

Secondary IDAAAQ1904Columbia University Medical Center

Secondary IDR01DK108643

Timeline

Milestones

Study first posted2016-03-03estimated

Primary completion2021-07-29actual

Study completion2021-07-29actual

Last update posted2022-11-15actual

Study start2016-01 (month precision)

Assets

Investigational agents

Avexitide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•BMI >35 kg/m2 BMI

•BMI < 65 kg/m2

•Preparing to undergo Roux-en-Y gastric bypass or gastric sleeve (RYGB/GS) surgery at St. Luke-Roosevelt Hospital

•Within the 18-65 age range

•Blood pressure under <160/100 mmHg

•Fasting triglyceride <600 mg/dl

•No recent (last 6 months) history of cardiovascular disease.

•Prior history of angioplasty or coronary artery bypass surgery with a normal stress test will not be a contraindication.

Exclusion criteria

•Diabetes Mellitus

•Active cancer

•Unstable angina

•Recent stroke

•Current therapy that may affect glucose metabolism such as glucocorticoids, adrenergic agents

•Active infection

•Kidney failure

•Severe liver dysfunction

•Heavy alcohol use

•Severe respiratory or cardiac failure

•Pancreatitis

•History of bullous pemphigoid

•Pregnancy

•Patients who are currently or have had prior GLP-1 therapy.

•Patients with known hypersensitivity to Exendin 9-39 or similar products, albumin, sitagliptin and/or acetaminophen will also be excluded.

Additional exclusions for visits 4 and 5 ONLY:

•Patients at risk for heart disease, such as patients with a history of atherosclerotic cardiovascular disease and history of heart failure

•Renal impairment (eGFR˂60 Ml/MIN/1.73 M2)

•History of exfoliative skin conditions in particularly if occurring with a DPP-4 inhibitor use

•History of bullous pemphigoid and Stevens-Johnson syndrome.

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.