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ZepBound clinical trial data
Zepbound (generic name: tirzepatide) is an obesity treatment developed by Eli Lilly. This medication acts as a GLP-1/GIP receptor agonist,
and is expected to suppress appetite and promote weight loss.
The average weight loss effect of Zepbound over 72 weeks (approximately 1 year and 6 months)
is reported to be about 12-20%.
Continuing treatment has been shown to enable weight loss of up to 25.3%.
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The SURMOUNT-J study was 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 week 72 and the proportion of participants who achieved a weight loss of 5% or more. Participants were randomized to one of three groups: placebo, tirzepatide 10 mg, or tirzepatide 15 mg. After a four-week screening period, participants began receiving 2.5 mg of tirzepatide subcutaneously once weekly, with the dose increasing by 2.5 mg every four weeks. Once participants reached the prescribed dose (tirzepatide 10 mg or 15 mg) in each group, the dose was stabilized 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 over placebo in both tirzepatide groups.
Efficacy has been demonstrated with multiple doses
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The SURMOUNT-J study was 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 week 72 and the proportion of participants who achieved a weight loss of 5% or more. Participants were randomized to one of three groups: placebo, tirzepatide 10 mg, or tirzepatide 15 mg. After a four-week screening period, participants began receiving 2.5 mg of tirzepatide subcutaneously once weekly, with the dose increasing by 2.5 mg every four weeks. Once participants reached the prescribed dose (tirzepatide 10 mg or 15 mg) in each group, the dose was stabilized 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. Furthermore, when the secondary endpoints of achieving a 7% or greater, 10% or greater, 15% or greater, and 20% or greater weight loss from baseline at 72 weeks were compared, both tirzepatide groups demonstrated superiority over the placebo group in all endpoints.
Proven effective in controlling blood sugar
The study also examined the proportion of participants who achieved improvement in obesity-related health problems at 72 weeks. The proportion of participants in whom two or more of the following health problems were reduced to 0 or 1 (participants with severe obesity who had at least one health problem reduced to 0) 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. Furthermore, the improvement rate for each was 92.5% in the tirzepatide 10 mg group and 97.8% in the tirzepatide 15 mg group, compared to 28.0% in the placebo group. The improvement rate for dyslipidemia was 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 10mg group and 77.4% in the tirzepatide 15mg group, compared with 9.8% in the placebo group.
Incidence of adverse events
The incidence 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 placebo, 11.0% in the tirzepatide 10 mg, and 6.5% in the tirzepatide 15 mg groups. Adverse events occurring in 5% or more of the tirzepatide groups during the study period included 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 collected in clinical trials
Adverse Reactions in Adults Receiving Zepbound (≥2% and >= placebo)
Table of Adverse Reaction Incidence Rates from the SURMOUNT-1 and SURMOUNT-2 Trials
SURMOUNT-1 Trial: 2,539 adult patients with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) without diabetes
SURMOUNT-2 Trial: 938 patients with diabetes and BMI ≥ 27 kg/m²
In trials involving patients with type 2 diabetes, hypoglycemia (plasma glucose < 54 mg/dL) was reported in 4.2% of patients receiving Zepbound versus 1.3% of patients receiving placebo.
In trials involving obese/overweight adults without type 2 diabetes, hypoglycemia was not systematically captured; however, plasma glucose <54 mg/dL was reported in 0.3% of patients receiving Zepbound and in no patients receiving placebo.
This table shows common adverse events associated with Zepbound use in two Phase 3 placebo-controlled trials. Percentages indicate the number of adult patients who reported experiencing an adverse event at least once during treatment.
Reference: https://zepbound.lilly.com/hcp/clinical-data
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Treatment discontinuation rates in clinical trials
The majority of adults who discontinued Zepbound due to side effects did so within a few months of starting treatment because of gastrointestinal side effects.
The most common side effects occurring more frequently with Zepbound than with placebo were gastrointestinal-related.
Most reports of nausea, vomiting, and diarrhea occurred during dose escalation and decreased over time.
Studies were conducted in adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related complication.
In clinical trials of Zepbound, patients receiving Zepbound (5 mg 56%, 10 mg 56%, 15 mg 56%) experienced a higher incidence of gastrointestinal side effects than those receiving placebo (30%).
Table of pooled treatment discontinuation rates from the SURMOUNT-1 and SURMOUNT-2 trials
SURMOUNT-1 Trial: 2,539 adult patients with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) without diabetes
SURMOUNT-2 Trial: 938 diabetic patients with BMI ≥ 27 kg/m²