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IRCT20150303021315N42 IRCT 2026-05-20 CinnaGen Company Before-after study of Spartina® (CinnaGen Co.) Evaluating the effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen) in patients with prediabetes and overweight or obesity 2026-04-21 anticipated 34 Complete https://irct.ir/trial/90147 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment. 4 Prediabetes and overweight or obesity. Intervention group: Tirzepatide (2.5–7.5 mg once weekly), dose should be increased to 5 mg after the first month in case of good tolerability. 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 St., Vanak Sq
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 Kafi.H@orchidpharmed.com Orchid Pharmed Co. scientific Dr. Jalaledin Mirzay Razaz
Tehran, Quds town (the West) Shahid Farahzadi Boulevard, Shahid Hafezi Street (Western purple) Plaque 7
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 Jmrazaz@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Male or female ≥18 years of age Body mass index (BMI) ≥ 27 or waist circumference (WC) ≥ 94 cm (Men) / ≥ 80 cm (Women). Willingness for signing and having signed the informed consent form Confirmed prediabetes diagnosis (100 ≤ Fasting blood sugar (FBS) ≤ 125 OR 5.6 ≤ HbA1C ≤ 6.4 OR 140 ≤ 2-hours post prandial glucose ≤ 199) 18 years no limit Both Prior use of any glucagon-like peptide-1 (GLP -1) agonist in the last 6 months Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data (e.g. acute pancreatitis/suspicious for pancreatitis, acute cholecystic disorders, severe hypoglycemia, hypersensitivity to the drug class, severe or sustain gastroenteric adverse events )grade 3 or higher)) Pregnancy or breast-feeding Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) Diabetes diagnosis Treatment - Drugs Intervention group: Tirzepatide (2.5–7.5 mg once weekly), dose should be increased to 5 mg after the first month in case of good tolerability Mean of fasting blood sugar (FBS) at day 90. Timepoint: Day 90. Method of measurement: Laboratory test. Mean change from baseline in FBS at day 90. Timepoint: Day 0, Day 90. Method of measurement: Laboratory test. Proportion of patients with equal to or more than 5% weight loss at day 90. Timepoint: Day 0, Day 90. Method of measurement: Weighting with scale. Percent change in body weight from baseline till day 90. Timepoint: Day 0, Day 90. Method of measurement: Weighting with scale. Absolute change in body weight from baseline till day 90. Timepoint: Day 0, Day 90. Method of measurement: Weighting with scale. Mean change from baseline in body mass index (BMI) at day 90. Timepoint: Day 0, Day 90. Method of measurement: Division of weight by square of height. Mean change from baseline in waist circumference (WC) at day 90. Timepoint: Day 0, Day 90. Method of measurement: Measurement by tape. Mean change from baseline in systolic blood pressure at day 90. Timepoint: Day 0, Day 90. Method of measurement: Using Sphygmomanometer. Mean change from baseline in diastolic blood pressure at day 90. Timepoint: Day 0, Day 90. Method of measurement: Using Sphygmomanometer. Proportion of patients achieving normoglycemia at day 90. Timepoint: Day 90. Method of measurement: Lab oratory test. Mean change from baseline in HbA1C at day 90. Timepoint: Day 0, Day 90. Method of measurement: Lab oratory test. Mean change from baseline in homeostatic model assessment for insulin resistance (HOMA-IR) index at day 90. Timepoint: Day 0, Day 90. Method of measurement: Using HOMA-IR formula. Mean change from baseline in 10-years atherosclerotic cardiovascular disease (ASCVD ) risk at day 90. Timepoint: Day 0, Day 90. Method of measurement: Using 10-years ASCVD formula. CinnaGen Company Approved 2026-04-18 Ethics Committee of Shahid Beheshti University of Medical Sciences Tehran, Chamran Highway, Evin, next to Taleghani Hospital, Building No. 2, Deputy of Research and Technology Tehran Tehran Iran (Islamic Republic of)