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IRCT20150303021315N45 IRCT 2026-10-08 CinnaGen Company Study to evaluate Spartina® (Tirzepatide manufactured by CinnaGen Co.) in adolescents with obesity and weight-related comorbidities Study to evaluate the effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen Co.) in adolescents with obesity and weight-related comorbidities 2026-10-22 anticipated 65 Recruiting https://irct.ir/trial/93856 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Overweight and obesity. Intervention group: Pre-filled syringes of Spartina® (Tirzepatide manufactured by CinnaGen Co.) will be prescribed and injected subcutaneously once a week with a dose starting from 2.5 mg/weekly and titrated up based on the physician’s opinion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Hamidreza Kafi
No 42, Attar Neyshaboori St., Vanak Sq., Tehran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 Kafi.H@orchidpharmed.com Orchid Pharmed scientific Dr. Fahimeh Soheilipour
Tehran, Modares Highway (North), Shahid Vahid Dastgerdi Street (formerly Zafer), No. 193.
Tehran Iran (Islamic Republic of) ۱۹۱۹۸۱۶۷۶۳ +98 21 2304 6200 fsoheilipour@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Male or female between 12 and <18 years of age Obesity, defined as BMI ≥ 95th percentile for age and sex (on age- and gender-specific growth chart for diagnosis of obesity) ORHave overweight, as defined by BMI ≥ 85th percentile but < 95th percentile for age and sex, on age- and sex-specific growth chart, with at least one weight-related comorbidity, including but not limited to: 1.Dyslipidemia 2.Prehypertension/Hypertension 3.Metabolic dysfunction-associated steatotic liver disease 4.Obstructive sleep apnea 5.Prediabetes 6.Type 2 Diabetes Mellitus (T2DM) with an HbA1C < 9% 7.Polyendocrine metabolic ovarian syndrome Capable of giving informed consent by a legal representative and assent by a study participant (when applicable) 12 years 18 years Both Prior use of any GLP-1 agonist in the last 6 months Having undergone or planning to undergo a weight reduction procedure, such as, but not limited to: a.Gastric bypass b.Sleeve gastrectomy c.Restrictive bariatric surgeries d.Any other procedure intended to result in weight reduction Pregnancy or breastfeeding Prepubertal stage (Tanner stage 1) Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) Have type 1 diabetes mellitus Any condition or circumstance that, according to the investigator, might pose a risk to the subject if they are enrolled or interfere with the ability to acquire satisfactory clinical data E66 Overweight and obesity Treatment - Drugs Intervention group: Pre-filled syringes of Spartina® (Tirzepatide manufactured by CinnaGen Co.) will be prescribed and injected subcutaneously once a week with a dose starting from 2.5 mg/weekly and titrated up based on the physician’s opinion Change in body mass index (BMI) standard deviation score (Z-score) from baseline until week 24. Timepoint: BMI: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer, rounded to the nearest centimeterMeasuring weight with a scaleBMI = weight (Kg)/ Height (m2)Z-score will be calculated based on the LMS tables provided by WHO. •Percentage of participants who achieve BMI reduction of ≥ 5% from baseline until week 12. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percentage of participants who achieve BMI reduction of ≥ 5% from baseline until week 24. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percentage of participants who achieve BMI reduction of ≥ 10% from baseline until week 12. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percentage of participants who achieve BMI reduction of ≥ 10% from baseline until week 24. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percentage of participants who achieve BMI reduction of ≥ 15% from baseline until week 12. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percentage of participants who achieve BMI reduction of ≥ 15% from baseline until week 24. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percent change in BMI from baseline until week 24. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Absolute change in BMI from baseline until week 24. Timepoint: BMI:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring height with a stadiometer and weight with a scaleBMI = weight (Kg)/ Height (m2). Percent change in body weight from baseline until week 12. Timepoint: Body weight:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring weight with a scale. Absolute change in body weight from baseline until week 12. Timepoint: Body weight:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring weight with a scale. Percent change in body weight from baseline until week 24. Timepoint: Body weight:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring weight with a scale. Absolute change in body weight from baseline until week 24. Timepoint: Body weight:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring weight with a scale. Percent change in waist circumference (WC) from baseline until week 24. Timepoint: WC:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring WC with a tape meter. Absolute change in WC from baseline until week 24. Timepoint: WC:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring WC with a tape meter. Percent change in WC from baseline until week 12. Timepoint: WC:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring WC with a tape meter. Absolute change in WC from baseline until week 12. Timepoint: WC:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24. Method of measurement: Measuring WC with a tape meter. Assessment of the adverse events (including treatment-emergent adverse events) based on the investigator’s opinion during the study period. Timepoint: Screening, Week 4, Week 8, Week 12, Week 16, Week 20 & Week 24. Method of measurement: Adverse events occurred during the study based on physician assessment. CinnaGen Company Approved 2026-10-03 Iran University of Medical Sciences Ethics Committee Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)