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NOVO-GLP1

TerminatedPhase 4Results posted

Treatment of GLP-1 for Diabetic Bariatric Patients

GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial

Lead sponsor

Geisinger Clinic

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Bariatric Surgery Candidate, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•PARTIAL REMISSION OF DIABETES

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 IDNCT04624672

Org study ID2020-0937

Secondary IDU1111-1242-4068NOVO Nordisk

Timeline

Milestones

Study first posted2020-11-12actual

Study start2021-08-25actual

Primary completion2022-07-18actual

Study completion2022-08-17actual

Results first posted2023-02-08actual

Last update posted2023-11-14actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Bariatric Surgery CandidateType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Candidates for Roux-en-Y Gastric Bypass Surgery with an established diagnosis of Type 2 diabetes requiring insulin treatment for glycemic control

2. Ability to provide informed consent before any trial-related activities

Exclusion criteria

1. Prior metabolic surgery procedure

2. Use of GLP-1 analogues for diabetes treatment at the time of recruitment

3. Known or suspected allergy to semaglutide or the excipients in semaglutide, or related products.

4. Contraindications to semaglutide which include a personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome-2 (MEN-2)

5. Previously randomized for participation in this trial.

6. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.

7. Type 1 diabetes

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.

Glycemic / diabetes

4 endpoints

Primary/registry result/low confidence

RATE OF PARTIAL REMISSION OF DIABETES

Time frame:11 months

categorical status, improvement

Primary/protocol endpoint/low confidence

RATE OF PARTIAL REMISSION OF DIABETES

Time frame:11 months

categorical status, improvement

Secondary/registry result/low confidence

RATE OF COMPLETE REMISSION OF DIABETES

Time frame:11 months

threshold achievement, improvement

componentsHbA1c <6.0% achievement, Fasting glucose, change

Secondary/protocol endpoint/low confidence

RATE OF COMPLETE REMISSION OF DIABETES

Time frame:11 months

categorical status, improvement

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.