DelfaGLP-1 Atlas

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OPTIMAL

RecruitingPhase 4

Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease

OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease

Assets

GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

1

Enrollment

70

estimated

Study population

Bariatric Surgery Candidate, Hepatic impairment, Obesity / overweight

Key I/E criterion

•BMI 35-70

Primary endpoint

•SF-36 physical

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 IDNCT07058155
Org study ID25-421

Timeline

Milestones

Study first posted2025-07-10actual
Study start2025-12-17actual
Last update posted2025-12-23actual
Primary completion2029-02-01estimated
Study completion2034-02-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutideTirzepatide

Study populations

Who this study enrolls

Bariatric Surgery CandidateHepatic impairmentObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Candidate for general anesthesia.

2. Age 18-70 years at consent.

3. BMI 35-70 kg/m² at first study visit.

4. Eligible for sleeve gastrectomy per ASMBS/IFSO 2022 guidelines.

5. Insurance coverage for metabolic surgery.

6. Current or prior anti-obesity medication use permitted.

7. Liver cirrhosis confirmed by biopsy or non-invasive assessment.

8. Clinically significant portal hypertension (HVPG ≥ 10 mm Hg, or esophagogastric varices / portal-hypertensive gastropathy, or imaging evidence of collaterals/dilated portal vein).

9. Able and willing to provide informed consent and comply with study procedures.

10. Women of child-bearing potential: negative urine pregnancy test at screening and randomization and agreement to reliable contraception for 2 years.

Exclusion criteria

1. Prior bariatric/metabolic surgery (except removed devices ≥ 3 months earlier).

2. Prior complex foregut surgery.

3. History of solid-organ transplant.

4. Severe pulmonary disease (FEV1 < 50 % predicted).

5. Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months.

6. ASA class IV or V uncompensated cardiopulmonary disease.

7. Left-ventricular ejection fraction < 25 % or MI/unstable angina/stroke/heart surgery/coronary stent within 6 months.

8. Hiatal hernia > 7 cm or LA grade C/D erosive esophagitis.

9. Active Crohn's disease.

10. Severe psychiatric illness, dementia, active psychosis, history of suicide attempt, or alcohol/substance abuse within 12 months.

11. Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception.

12. Malignancy within the prior 12 months (except non-melanoma skin cancer).

13. Life expectancy < 2 years in investigator's judgment.

14. Investigational therapy within 3 months.

15. Acute pancreatitis ≤ 90 days.

16. Portal vein thrombosis at screening.

17. Decompensated cirrhosis (moderate/large ascites, hepatic encephalopathy, or listed for liver transplant); small ascites or prior variceal bleed allowed.

18. Total bilirubin > 3 mg/dL, INR > 1.7, or platelets < 50 000/µL (within 1 month).

19. Significant alcohol intake (> 14 units/week women, > 21 units/week men) within the prior 12 months.

20. eGFR < 45 mL/min/1.73 m² or on dialysis (within 1 month).

21. AIDS.

22. Unable to understand study or give consent.

23. Plans to move more than 3 hours from Cleveland within 6 months.

24. Previous randomization in this trial.

25. Any condition that, in the investigator's opinion, places the subject at undue risk.

Endpoints (8)

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

Patient-reported / QoL
5
Weight & body composition
1
Glycemic / diabetes
1
MASH / liver
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent Total Body-Weight Loss (%TBWL) at 6 Months

Time frame:At 6 months after treatment initiation

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

Change in HbA1c (%)

Time frame:Baseline and 6 months (Week 24) after treatment initiation

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Secondary/protocol endpoint

Incidence of Serious Complication Composite Within 6 Months

Time frame:Up to 6 months after treatment initiation

Hepatic-decompensation composite

composite event, event

componentsHepatic-decompensation composite, pulmonary embolism, Kidney-replacement therapy, All-cause death, blood transfusion, sepsis

Patient-reported / QoL

5 endpoints
Primary/protocol endpoint

Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months

Time frame:At 6 months after treatment initiation (Day 0 = TIPS placement date or start of medical management).

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Physical Component Score From Baseline to 1 Month

Time frame:Baseline and 1 month

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Mental Component Score From Baseline to 1 Month.

Time frame:Baseline and 1 month.

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Physical Component Score From Baseline to 3 Months

Time frame:Baseline and 3 months

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 Mental Component Score From Baseline to 3 Months.

Time frame:Baseline and 3 months.

SF-36 mental

change from baseline, improvement

Publications (10)

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.