Zepbound clinical trial data
Zepbound (generic name: tirzepatide) is an obesity treatment drug developed by Eli Lilly. This drug acts as a GLP-1/GIP receptor agonist,
It is believed to have the effect of suppressing appetite and helping with weight loss.
The average diet effect of Zepbound lasts for 72 weeks (about 1 year and 6 months).
It is said to be about 12-20% .
Continuing treatment has been shown to result in weight loss of up to 25.3%.
SURMOUNT-J is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study conducted in Japanese adults with obesity or severe obesity and obesity-related health problems. The primary endpoints were the mean percent change in body weight from baseline to 72 weeks, and the proportion of study participants who achieved a weight loss of 5% or more. Study participants were randomized to one of three groups: placebo, tirzepatide 10mg, or tirzepatide 15mg. After a 4-week screening period, participants were administered 2.5mg subcutaneously once weekly, and the dose was increased by 2.5mg every 4 weeks during the dose titration period. When each group reached the prescribed dose (tirzepatide 10mg or 15mg), the dose was fixed and continued until the end of the 72-week study. The mean change in body weight from baseline at 72 weeks was 1.7% in the placebo group (n=75), 17.8% in the tirzepatide 10 mg group (n=71), and 22.7% in the tirzepatide 15 mg group (n=76), demonstrating superiority to the placebo group for both tirzepatide groups.
Efficacy has been demonstrated with multiple doses
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SURMOUNT-J is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study conducted in Japanese adults with obesity or severe obesity and obesity-related health problems. The primary endpoints were the mean percent change in body weight from baseline to 72 weeks, and the proportion of study participants who achieved a weight loss of 5% or more. Study participants were randomized to one of three groups: placebo, tirzepatide 10mg, or tirzepatide 15mg. After a 4-week screening period, participants were administered 2.5mg subcutaneously once weekly, and the dose was increased by 2.5mg every 4 weeks during the dose titration period. When each group reached the prescribed dose (tirzepatide 10mg or 15mg), the dose was fixed and continued until the end of the 72-week study.
The percentage of study participants who achieved a 5% or greater weight loss was 94.4% in the tirzepatide 10mg group and 96.1% in the tirzepatide 15mg group, compared to 20.0% in the placebo group, demonstrating superiority over the placebo group in both groups. In addition, when the secondary endpoints of achieving a 7% or greater weight loss, 10% or greater weight loss, 15% or greater weight loss, and 20% or greater weight loss from baseline at 72 weeks were compared, superiority over the placebo group was demonstrated in both tirzepatide groups in all endpoints.
Proven effective in controlling blood sugar
The study also looked at the percentage of participants who experienced improvements in obesity-related health disorders at 72 weeks. The percentage of participants who achieved a score of 0 or 1 for two or more of the following health disorders (impaired glucose tolerance, dyslipidemia, and nonalcoholic fatty liver disease in the severely obese) was 70.0% in the tirzepatide 10 mg group and 79.7% in the tirzepatide 15 mg group compared to 11.1% in the placebo group. Improvements in glucose tolerance were 28.0% in the placebo group, 92.5% in the tirzepatide 10 mg group and 97.8% in the tirzepatide 15 mg group, and 25.0% in the placebo group, respectively. Improvements in dyslipidemia were 72.4% in the tirzepatide 10 mg group and 81.1% in the tirzepatide 15 mg group compared to 25.0% in the placebo group. The incidence of non-alcoholic fatty liver disease was 69.5% in the tirzepatide 10 mg group and 77.4% in the tirzepatide 15 mg group compared with 9.8% in the placebo group.
有害事象の発現率
The proportion of all adverse events observed during the study was 69.3% in the placebo group (n=75), 83.6% in the tirzepatide 10 mg group (n=73), and 85.7% in the tirzepatide 15 mg group (n=77). Serious adverse events were observed in 6.7% of the placebo group, 11.0% in the tirzepatide 10 mg group, and 6.5% in the tirzepatide 15 mg group. Adverse events observed in 5% or more of the tirzepatide groups during the study were COVID-19, constipation, fever, nausea, diarrhea, vomiting, decreased appetite, nasopharyngitis, back pain, abdominal discomfort, headache, immune reactions, injection site reactions, and arthralgia. Compared to the placebo group, the incidence of gastrointestinal disorders (e.g., constipation, nausea, and diarrhea) was particularly high.
Adverse reactions recorded in clinical trials
Adverse Reactions in Adults Receiving Zepbound (≥2% and >= placebo)
Table showing the incidence of adverse reactions compiled from the SURMOUNT-1 and SURMOUNT-2 trials
SURMOUNT-1: 2,539 adult patients without diabetes who were obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2)
SURMOUNT-2 study: 938 diabetic patients with a BMI of 27 or higher
In a study in patients with type 2 diabetes, hypoglycemia (plasma glucose < 54 mg/dL) was reported in 4.2% of patients receiving Zepbound compared with 1.3% of patients receiving placebo.
In a study of obese/overweight adults without type 2 diabetes, hypoglycemia was not systematically captured, with plasma glucose <54 mg/dL reported in 0.3% of Zepbound-treated patients compared with 0.0% of placebo-treated patients.
This table shows common side effects associated with the use of Zepbound in two Phase 3 placebo-controlled trials. The percentages indicate the number of adult patients who reported experiencing at least one side effect during treatment.
臨床試験での治療中止率
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副作用のためにゼップバウンドを中止した成人の大多数は、治療開始から数か月以内に胃腸の副作用のために中止した
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プラセボよりもゼップバウンドでより頻繁に発生する最も一般的な副作用は消化器系関連でした
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吐き気、嘔吐、下痢の報告のほとんどは用量増加中に発生し、時間の経過とともに減少した
肥満（BMI ≥ 30 kg/m 2）または少なくとも1つの体重関連合併症を伴う過体重（BMI ≥ 27 kg/m 2 ）の成人を対象に研究されました。
ゼップバウンドの臨床試験では、ゼップバウンドを投与された患者（5 mg 56%、10 mg 56%、15 mg 56%）の方がプラセボ（30%）よりも胃腸の副作用の発生率が高いことが分かりました。
SURMOUNT-1試験およびSURMOUNT-2試験から統合された治療中止率の表
SURMOUNT-1試験：糖尿病を有さない肥満（BMI ≥ 30 kg/m 2）または過体重（BMI ≥ 27 kg/m 2） 2,539 人の成人患者が対象
SURMOUNT-2試験：BMI27以上の糖尿病患者938人を対象