A combination kit consisting of a pre-assembled syringe and an injector. Colorless to pale yellow to pale brown, clear or slightly opalescent liquid. pH 6.5–7.5. Osmolarity ratio of approximately 1.

One package contains Chilizepatide 2.5, 5, 7.5, 10, 12.5, and 15 mg.

Excipients (same for all strengths): disodium hydrogen phosphate heptahydrate 0.7 mg, sodium chloride 4.1 mg, hydrochloric acid as needed, sodium hydroxide as needed.

C₂₂₅H₃₄₈N₄₈O₆₈　Molecular weight 4813.45; white powder. Positions 2 and 13 are 2-methyl-Ala; the C-terminus is an amidated Ser; 1,20-docosanedioic acid is linked to Lys at position 20 via a Glu and two 8-amino-3,6-dioxooctanoic acid linkers. A 39-amino acid synthetic peptide.

Obesity: Must have at least one of the following conditions—hypertension, dyslipidemia, or impaired glucose tolerance (type 2 diabetes, impaired glucose tolerance, etc.)—and for whom diet and exercise alone are insufficient, and who have a BMI of ≥27 along with at least two obesity-related health complications, or a BMI of ≥35.

Moderate-to-severe OSA: Limited to patients with a BMI ≥ 27 and an AHI ≥ 15/h.

Dosage for Obesity:Start with 2.5 mg once weekly, then increase by 2.5 mg every 4 weeks until reaching 10 mg weekly. The dose may be reduced to 5 mg, or increased to 15 mg at intervals of ≥4 weeks.

OSA dosage:Start with 2.5 mg once a week, increasing the dose by 2.5 mg every 4 weeks until reaching 15 mg per week; if intolerance occurs, adjust the dose within the range of 10–15 mg.

Administer on a fixed day of the week. If a dose is missed, administer it immediately provided at least 72 hours have elapsed since the previous dose and continue on the original day of the week; if less than 72 hours have elapsed, skip the dose. Changing the day of administration requires a minimum interval of 72 hours since the previous dose. In cases of gastrointestinal intolerance, consider reducing the dose or delaying the gradual increase. For patients with obesity, maintain a dose of 5 mg per week based on weight loss and tolerance.

GIP and GLP-1 in the central nervous system regulate appetite, while GIP in adipocytes promotes lipid metabolism. The C20 fatty acid side chain binds to albumin, with a half-life (t½) of approximately 5–6 days and an absolute bioavailability of approximately 80%. Protein binding is 99.06%. AUC values are similar in the abdomen, upper arm, and thigh. Trace amounts of 4.6–7.2 ng/mL have been detected in breast milk.

Domestic obesity trial: 72-week weight change: 10 mg −18.41 TP3T, 15 mg −22.61 TP3T, placebo −1.81 TP3T; weight loss of 94.91 TP3T among participants with a baseline weight of ≥51 TP3T / 96.91 TP3T vs. 21.21 TP3T. In an international prediabetic population, the hazard ratio (HR) for developing type 2 diabetes at 176 weeks was 0.06.

OSA 52-week AHI: Without PAP, −28.1 vs. −4.2/h; with PAP, −29.4 vs. −7.9/h.

21. A drug risk management plan must be developed and implemented.

22. Each specification: 0.5 mL × 2 sets.

24. Eli Lilly Japan—Medical Information Inquiries: TEL 0120-360-605 medical.lilly.com/jp
Tanabe Pharma Medication Consultation Center TEL 0120-753-280

25. Under the “Obesity” category, only “hypertension, dyslipidemia, or type 2 diabetes” are eligible for insurance coverage. (Insurance and Medical Affairs Notice No. 0518-2: May 18, Reiwa 8)

26. Manufacturer: Eli Lilly Japan K.K. / Distributor: Tanabe Pharma Co., Ltd. ® Registered Trademark