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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07262762

Enrollment

175

Registered

2025-12-04

Start date

2025-11-11

Completion date

2026-07-05

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity & Overweight

Keywords

obesity, overweight, tirzepatide

Brief summary

The goal of this study is to evaluate Effectiveness and safety of Spartina® (Tirzepatide) in male or female participants with obesity and overweight. The main questions which are aimed to be answered: 1. Is Spartina® (Tirzepatide) effective in the treatment of obesity and overweight? 2. Is Spartina® (Tirzepatide) safe in the treatment of obesity and overweight? In this study, there is no comparison group. Participants receive Spartina® (Tirzepatide)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Proportion of patients with ≥5% weight loss	day 0, 180

Secondary

Measure	Time frame	Description
Percent change in body weight from baseline	day 0, 90	—
Absolute change in body weight from baseline	day 0, 90	—
Mean change in Body Mass Index from baseline	day 0, 90, 180	24.9\<BMI\<30 and more than 30 are considered overweight and obesity, respectively. More BMI decrease is related to the better response.
Mean change in waist circumference from baseline	day 0, 90, 180	—
Proportion of patients with ≥5% weight loss	day 0, 90	—
Proportion of patients with ≥10% weight loss	day 0, 90, 180	—
Proportion of patients with ≥15% weight loss	day 0, 180	—
Assessment of the adverse events (including Treatment Emergent Adverse Events)	during study period	—
Assessment of immunogenicity at screening, day 90, and day 180	day 0, 90, 180	—

Countries

Iran

Outcome results