Prediabetes and overweight or obesity.
Conditions
Interventions
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.
Sponsors
CinnaGen Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of fasting blood sugar (FBS) at day 90. Timepoint: Day 90. Method of measurement: Laboratory test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed