Telephone reception hours: 8:30-16:30
(Until 13:30 on Saturdays, closed on Sundays and public holidays)
Provided by HDC Atlas Clinic
Physician in charge: Yoshihiko Suzuki, diabetes specialist
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.
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%) had 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