Spartina (tirzepatide) for adults with obesity or overweight

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

This project will try Spartina (tirzepatide) in adults with obesity or overweight to see if it helps them lose weight and is safe.

Quick facts

• Study type: Observational
• Enrollment: 175 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cinnagen (Industry-sponsored)
• Locations: 14 sites (Tabriz, East Azerbaijan Province and 13 other locations)
• Trial ID: NCT07262762 on ClinicalTrials.gov

What this trial studies

This is an observational study in which adults prescribed Spartina (tirzepatide) are followed without a comparison group to record outcomes in routine care. Eligible participants are ≥18 years with BMI ≥30 kg/m² or ≥27 kg/m² plus at least one weight-related comorbidity, and common exclusions include recent GLP-1 use, type 1 diabetes, pregnancy, and specific thyroid cancer risks. Investigators will collect effectiveness measures such as weight change and safety data including adverse events over the follow-up period. The study is sponsored by Cinnagen and is being conducted at three clinic sites in Iran.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI ≥30 kg/m² or BMI ≥27 kg/m² plus at least one weight-related comorbidity who are able to give informed consent and do not meet exclusion criteria are ideal candidates.

Not a fit: People with type 1 diabetes, recent use of GLP-1 agonists within six months, pregnant or breastfeeding individuals, or those with a personal or family history of medullary thyroid carcinoma or MEN2 are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, this could show whether Spartina helps adults with obesity lose weight in real-world care and clarify its common side effects.

How similar studies have performed: Large randomized trials of tirzepatide have shown substantial weight loss compared with placebo, so this observational work builds on an approach that has already shown strong efficacy in controlled trials.

Eligibility criteria

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)

Where this trial is running

Tabriz, East Azerbaijan Province and 13 other locations

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

Study contacts

• Study coordinator: Hamidreza Kafi, Ph.D

Conditions Obesity & Overweight; obesity; overweight; tirzepatide