DelfaGLP-1 Atlas

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RecruitingPhase 4

2024 Tirzepatide-Bariatric Surgery

Preoperative Tirzepatide for Bariatric Surgery

Lead sponsor

Marlene Starr

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

Bariatric Surgery, Bariatric Surgery Candidate, Obesity / overweight

Key I/E criterion

•BMI ≥40

Primary endpoints

•Hs-CRP, change•Inflammatory markers interleukin 6 (IL-6)•Inflammatory markers tumor necrosis factor (TNF)

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 IDNCT06721507
Org study ID97933

Timeline

Milestones

Study first posted2024-12-06actual
Study start2025-03-27actual
Last update posted2026-05-14actual
Primary completion2026-12-31estimated
Study completion2026-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Bariatric SurgeryBariatric Surgery CandidateObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or gastric bypass surgery
•BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
•have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
•enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

Exclusion criteria

•any contraindication to the use of tirzepatide (per package insert)
•Personal or family history of medullary thyroid carcinoma
•Patients with Multiple Endocrine Neoplasm syndrome type 2
•Hypersensitivity to tirzepatide
•History of pancreatitis
•Type 1 Diabetes
•patients with active, untreated or symptomatic cholelithiasis or jaundice
•consistent use of a GLP-1 or GLP-1/GIP receptor agonist, over the past 90 days
•diagnosed autoimmune disease
•current use of immunosuppressive agents or use within the past 30 days
•moderate or severe substance use disorder according to DSM-5 criteria
•uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
•female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
•a prisoner

Endpoints (23)

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

Cardiometabolic biomarkers
13
Other (unclassified)
5
Glycemic / diabetes
3
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in weight

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in Hemoglobin A1c

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

change in blood glucose

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

change from baseline, improvement

Secondary/protocol endpoint

change in insulin

Time frame:Baseline, 3 months, post-drug, 1-, 6-, and 12-months post surgery

change from baseline, improvement

Cardiometabolic biomarkers

13 endpoints
Primary/protocol endpoint

Change in inflammatory markers c reactive protein (CRP)

Time frame:Baseline and 3 months post-drug

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Primary/protocol endpoint

Change in inflammatory markers tumor necrosis factor (TNF)

Time frame:Baseline and 3 months post-drug

change from baseline, improvement

Primary/protocol endpoint

change in inflammatory markers (leptin)

Time frame:Baseline and 3 months post-drug

Leptin, change

change from baseline, improvement

Primary/protocol endpoint

change in inflammatory markers (adiponectin)

Time frame:Baseline and 3 months post-drug

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

change in inflammatory markers c reactive protein (CRP)

Time frame:1-, 3-, 6-, and 12-months post surgery

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

change in inflammatory markers tumor necrosis factor (TNF)

Time frame:1-, 3-, 6-, and 12-months post surgery

change from baseline, improvement

Secondary/protocol endpoint

change in inflammatory markers (leptin)

Time frame:1-, 3-, 6-, and 12-months post surgery

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

change in inflammatory markers (adiponectin)

Time frame:1-, 3-, 6-, and 12-months post surgery

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

change in blood pressure

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

change from baseline, improvement

Secondary/protocol endpoint

change in cholesterol

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

change from baseline, improvement

Secondary/protocol endpoint

change in high-density lipoprotein (HDL)

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

change in low-density lipoprotein (LDL)

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

change in triglycerides

Time frame:Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint/low confidence

30-day surgical complications

Time frame:1-, 3-, 6-, and 12-months post surgery

descriptive, event

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Change in inflammatory markers interleukin 6 (IL-6)

Time frame:Baseline and 3 months post-drug

change from baseline, improvement

Primary/protocol endpoint/low confidence

change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)

Time frame:Baseline and 3 months post-drug

change from baseline, improvement

Primary/protocol endpoint/low confidence

RNA sequencing

Time frame:at time of surgery

descriptive

Secondary/protocol endpoint/low confidence

change in inflammatory markers interleukin 6 (IL-6)

Time frame:1-, 3-, 6-, and 12-months post surgery

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)

Time frame:1-, 3-, 6-, and 12-months post surgery

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.