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OpenTrials
Completed

NCT Number: NCT07262762

Spartina® (Tirzepatide) Effectiveness and Safety Evaluation

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)

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akbar Aliasgarzadeh Clinic, Tabriz, East Azerbaijan Province, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age
  • Willingness for signing and having signed the informed consent form
  • BMI ≥30 kg/m² or ≥27 kg/m² with ≥1 weight-related comorbidity

Exclusion criteria

  • Prior use of any GLP-1 agonist in the last 6 months
  • Type 1 diabetes mellitus
  • Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data
  • Pregnancy or breast-feeding
  • Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)

Treatment and study plan

Primary outcomes

  1. Proportion of patients with ≥5% weight loss

    Time frame: day 0, 180

Secondary outcomes

  1. Percent change in body weight from baseline

    Time frame: day 0, 90

  2. Absolute change in body weight from baseline

    Time frame: day 0, 90

  3. Percent change in body weight from baseline

    Time frame: day 0, 180

  4. Absolute change in body weight from baseline

    Time frame: day 0, 180

  5. Mean change in Body Mass Index from baseline

    Time frame: 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.

  6. Mean change in waist circumference from baseline

    Time frame: day 0, 90, 180

  7. Proportion of patients with ≥5% weight loss

    Time frame: day 0, 90

  8. Proportion of patients with ≥10% weight loss

    Time frame: day 0, 90, 180

  9. Proportion of patients with ≥15% weight loss

    Time frame: day 0, 180

  10. Assessment of the adverse events (including Treatment Emergent Adverse Events)

    Time frame: during study period

  11. Assessment of immunogenicity at screening, day 90, and day 180

    Time frame: day 0, 90, 180

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Registry information

Official study title

A Post-marketing Real-world Study for Evaluating Effectiveness and Safety of Spartina® (Tirzepatide Manufactured by CinnaGen) in Patients With Obesity and Overweight

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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