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CompletedNCT07262762Updated Jul 15, 2026

Spartina® (Tirzepatide) Effectiveness and Safety Evaluation

An observational study in Obesity & Overweight, sponsored by Cinnagen. Completed at 14 sites in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Cinnagen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
175
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Obesity & Overweight

Keywords

  • obesity
  • overweight
  • tirzepatide
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
175 participants (actual)
Patient registry
No
05

What researchers measure

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

    24.9\<BMI\<30 and more than 30 are considered overweight and obesity, respectively. More BMI decrease is related to the better response.

    Time frame: day 0, 90, 180

  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

06

Study locations

14 sites
  • Akbar Aliasgarzadeh Clinic
    Tabriz, East Azerbaijan Province, Iran
  • Dr. Mohammadhossein Dabbaghmanesh Clinic
    Shiraz, Fars, Iran
  • Behrang Motamed Clinic
    Rasht, Gilan Province, Iran
  • Seyed Mojtaba Mehrdad Clinic
    Rasht, Gilan Province, Iran
  • Mansoor Siavash Dastjerdi Clinic
    Isfahan, Isfahan, Iran
  • Sari Diabetes Research Center
    Sari, Mazandaran, Iran
  • Shokoofeh Bonakdaran Clininc
    Mashhad, Razavi Khorasan Province, Iran
  • Alireza Esteghamati clinic
    Tehran, Tehran Province, Iran
  • Farzad Hadaegh Clininc
    Tehran, Tehran Province, Iran
  • Imam Khomeini Hospital
    Tehran, Tehran Province, Iran
  • Iran University Endocrinology Research Center
    Tehran, Tehran Province, Iran
  • Mohammadreza Mohajeri Tehrani Clininc
    Tehran, Tehran Province, Iran
  • Khorshid Clinic
    Yazd, Yazd Province, Iran
  • Hajieh Bibi Shahbazian Clinic
    Ahvāz, Iran
07

Registry details

Key details

Study ID
NCT07262762
Lead sponsor
Cinnagen
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Nov 11, 2025
Primary completion
Jun 20, 2026
Completion
Jul 5, 2026
Last update
Jul 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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