DelfaGLP-1 Atlas

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TIR-REAL

Completed

Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients

More Than Weight Loss: Real-World Tirzepatide Use in Post-Bariatric Weight Regain and Preoperative Obesity Care

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

254

actual

Study population

Bariatric Surgery, Bariatric Surgery Candidate, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, % change

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 IDNCT07382180
Org study ID11182022

Timeline

Milestones

Study start2025-02-01actual
Primary completion2026-01-18actual
Study completion2026-01-18actual
Study first posted2026-02-02actual
Last update posted2026-02-03actual

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
Sampling methodNon probability sample

Study population text

The study population consists of adult patients with obesity managed within established bariatric and metabolic care pathways at participating referral centers. Participants are selected from individuals who initiate tirzepatide therapy as part of routine clinical practice, either for medical optimization prior to planned bariatric surgery or for the management of clinically significant weight regain following prior sleeve gastrectomy. All participants receive standard multidisciplinary care, including medical, nutritional, and metabolic evaluation, and are followed longitudinally through scheduled outpatient visits. The study population reflects a real-world clinical setting and includes patients with a broad range of obesity-related metabolic profiles, representative of routine bariatric practice.

Inclusion criteria

nclusion Criteria

•Adult patients aged 18 years or older.
•Diagnosis of obesity, defined according to standard clinical criteria, managed within a bariatric and metabolic care pathway.
•Initiation of tirzepatide therapy at a starting dose of 5 mg as part of routine clinical practice.
•Allocation to one of the following clinical cohorts:
•Patients with prior sleeve gastrectomy and clinically significant weight regain, defined as a ≥25% increase in body weight relative to the postoperative nadir weight, with a minimum interval of 36 months from surgery; or
•Patients with obesity undergoing preoperative medical optimization prior to planned bariatric surgery.
•Availability of complete baseline clinical and anthropometric data at treatment initiation.
•Planned clinical follow-up for at least 6 months after initiation of tirzepatide therapy.
•Ability to provide written informed consent for the use of clinical data for research purposes, according to local regulations.

Exclusion criteria

•Age younger than 18 years.
•Prior bariatric procedures other than sleeve gastrectomy (for the weight regain cohort).
•Current or previous treatment with tirzepatide before study enrollment.
•Use of other anti-obesity pharmacological agents during the observation period.
•Contraindications to tirzepatide therapy according to the approved product label.
•Pregnancy or breastfeeding at the time of treatment initiation or during follow-up.
•Presence of severe medical, psychiatric, or cognitive conditions that, in the investigator's judgment, could interfere with adherence to treatment or follow-up assessments.
•Incomplete baseline data or anticipated inability to complete the planned 6-month follow-up.

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

Weight & body composition
2
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percentage Total Body Weight Loss (%TBWL)

Time frame:From baseline (initiation of tirzepatide therapy) to 6 months of treatment

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:From baseline (initiation of tirzepatide therapy) to 6 months of treatment

BMI, change

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in Mood Status

Time frame:From baseline (initiation of tirzepatide therapy) to 6 months of treatment

PGI, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety and Tolerability of Tirzepatide

Time frame:From baseline (initiation of tirzepatide therapy) to 6 months of treatment

Treatment-emergent AEs (any)

descriptive, event

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.