Tirzepatide Once Weekly for the Treatment of Obesity-4 - SURMOUNT-4

Jan 02, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
Eli Lilly
Date Published:
12/11/2023
Date Updated:
01/02/2024
Original Posted Date:
01/02/2024
References

Contribution To Literature:

The SURMOUNT-4 trial showed that tirzepatide improves weight loss compared with placebo.

Description:

The goal of the trial was to evaluate tirzepatide compared with placebo among obese patients.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Open-label
  • Placebo

Obese patients were randomized to once weekly subcutaneous tirzepatide (n = 335) versus placebo (n = 335). Tirzepatide was started at 2.5 mg during a lead-in phase and increased by 2.5 mg every 4 weeks until maximum tolerated dose of 10-15 mg was achieved. At 36 weeks, patients were randomized to their maximum tolerated dose of tirzepatide versus placebo.

  • Total number of enrollees: 670
  • Duration of follow-up: 88 weeks
  • Mean patient age: 48 years
  • Percentage female: 71%

Inclusion criteria:

  • Patients ≥18 years of age with obesity (body mass index [BMI] ≥30 kg/m2)

Exclusion criteria:

  • Diabetes
  • Planned surgical treatment for obesity
  • Use of weight loss medication within 3 months of enrollment

Principal Findings:

The primary outcome, percent change in body weight from week 36 to 88, was -5.5 in the tirzepatide group vs. 14.0 in the placebo group (p < 0.001).

Secondary outcomes:

  • Weight reduction of ≥20% from 0 to 88 weeks: 69.5% for tirzepatide vs. 12.6% for placebo (p < 0.001)
  • ≥1 adverse event: 60.3% for tirzepatide vs. 55.8% for placebo

Interpretation:

Among obese patients, tirzepatide improves weight loss compared with placebo. After the lead-in period, patients randomized to placebo regained weight, while those randomized to tirzepatide continued to lose weight. Adverse events were similar between treatment arms. Further studies are needed to determine the risks and benefits of long-term use of tirzepatide.

References:

Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA 2023;Dec 11:[Epub ahead of print].

Clinical Topics: Prevention

Keywords: Glucagon-Like Peptide-1 Receptor, Obesity, Weight Loss


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