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Spartina® (Tirzepatide) Effectiveness and Safety Evaluation
A Post-marketing Real-world Study for Evaluating Effectiveness and Safety of Spartina® (Tirzepatide Manufactured by CinnaGen) in Patients With Obesity and Overweight
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
14
Recruiting sites
14
Enrollment
175
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•≥5% weight-loss responders
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
Primary care clinic
Inclusion criteria
1. Male or female ≥18 years of age
2. Willingness for signing and having signed the informed consent form
3. BMI ≥30 kg/m² or ≥27 kg/m² with ≥1 weight-related comorbidity
Exclusion criteria
1. Prior use of any GLP-1 agonist in the last 6 months
2. Type 1 diabetes mellitus
3. Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data
4. Pregnancy or breast-feeding
5. Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
Endpoints (12)
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
10 endpointsProportion of patients with ≥5% weight loss
Time frame:day 0, 180
≥5% weight-loss responders
threshold achievement, improvement
Percent change in body weight from baseline
Time frame:day 0, 90
Body weight, % change
percent change from baseline, improvement
Absolute change in body weight from baseline
Time frame:day 0, 90
Body weight, absolute change (kg)
change from baseline, improvement
Percent change in body weight from baseline
Time frame:day 0, 180
Body weight, % change
percent change from baseline, improvement
Absolute change in body weight from baseline
Time frame:day 0, 180
Body weight, absolute change (kg)
change from baseline, improvement
Mean change in Body Mass Index from baseline
Time frame:day 0, 90, 180
BMI, change
change from baseline, improvement
Mean change in waist circumference from baseline
Time frame:day 0, 90, 180
Waist circumference, change
change from baseline, improvement
Proportion of patients with ≥5% weight loss
Time frame:day 0, 90
≥5% weight-loss responders
threshold achievement, improvement
Proportion of patients with ≥10% weight loss
Time frame:day 0, 90, 180
≥10% weight-loss responders
threshold achievement, improvement
Proportion of patients with ≥15% weight loss
Time frame:day 0, 180
≥15% weight-loss responders
threshold achievement, improvement
Safety / tolerability / PK
2 endpointsAssessment of the adverse events (including Treatment Emergent Adverse Events)
Time frame:during study period
Treatment-emergent AEs (any)
descriptive, event
Assessment of immunogenicity at screening
Time frame:day 0, 90, 180
Immunogenicity (ADA)
descriptive
Provenance
Sources
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.