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Obesity & OverweightNCT07262762

Spartina® (Tirzepatide) Effectiveness and Safety Evaluation

An observational study of Obesity & Overweight, run by Cinnagen at 14 sites in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity & Overweight
How many people
175 participants
Where
14 sitesIran
Study dates
11 Nov 2025to 5 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Primary care clinic

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Iran14 sites

  • Hajieh Bibi Shahbazian Clinic

    Ahvāz

  • Mansoor Siavash Dastjerdi Clinic

    Isfahan, Isfahan

  • Shokoofeh Bonakdaran Clininc

    Mashhad, Razavi Khorasan Province

  • Behrang Motamed Clinic

    Rasht, Gilan Province

  • Seyed Mojtaba Mehrdad Clinic

    Rasht, Gilan Province

  • Sari Diabetes Research Center

    Sari, Mazandaran

  • Dr. Mohammadhossein Dabbaghmanesh Clinic

    Shiraz, Fars

  • Akbar Aliasgarzadeh Clinic

    Tabriz, East Azerbaijan Province

  • Alireza Esteghamati clinic

    Tehran, Tehran Province

  • Farzad Hadaegh Clininc

    Tehran, Tehran Province

  • Imam Khomeini Hospital

    Tehran, Tehran Province

  • Iran University Endocrinology Research Center

    Tehran, Tehran Province

  • Mohammadreza Mohajeri Tehrani Clininc

    Tehran, Tehran Province

  • Khorshid Clinic

    Yazd, Yazd Province

Other trials in Iran

About this study

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

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)

Keywords
obesity, overweight, tirzepatide
Medical subject headings
Obesity, Overweight

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with ≥5% weight loss

    Measured: day 0, 180

Secondary outcomes (11)

  1. Percent change in body weight from baseline

    Measured: day 0, 90

  2. Absolute change in body weight from baseline

    Measured: day 0, 90

  3. Percent change in body weight from baseline

    Measured: day 0, 180

  4. Absolute change in body weight from baseline

    Measured: 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.

    Measured: day 0, 90, 180

  6. Mean change in waist circumference from baseline

    Measured: day 0, 90, 180

  7. Proportion of patients with ≥5% weight loss

    Measured: day 0, 90

  8. Proportion of patients with ≥10% weight loss

    Measured: day 0, 90, 180

  9. Proportion of patients with ≥15% weight loss

    Measured: day 0, 180

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

    Measured: during study period

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

    Measured: day 0, 90, 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start11 Nov 2025
  3. Primary completion20 Jun 2026
  4. Study completion5 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07262762
Sponsor's protocol ID
TIR.CIN.AE.IV.04
Status last verified
Jul 2026
First submitted
23 Nov 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity & Overweight, run by Cinnagen at 14 sites in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with ≥5% weight loss (time frame: day 0, 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07262762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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