Oral Semaglutide Treatment Effect in People With Obesity - OASIS 1

Jul 17, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Novo Nordisk
Date Published:
06/25/2023
Date Updated:
07/17/2023
Original Posted Date:
07/17/2023
References

Contribution To Literature:

The OASIS 1 trial showed that semaglutide improves weight loss among patients with overweight/obesity.

Description:

The goal of the trial was to evaluate the oral glucagon-like peptide-1 analogue, semaglutide, compared with placebo among patients with overweight/obesity.

Study Design

  • Randomized
  • Parallel
  • Double-blind
  • Placebo

Patients with overweight/obesity without diabetes were randomized to semaglutide 50 mg daily (n = 334) vs. placebo (n = 333).

  • Total number of enrollees: 667
  • Duration of follow-up: 68 weeks
  • Mean patient age: 49 years
  • Percentage female: 74%

Inclusion criteria:

  • At least 18 years of age
  • Obesity
  • Overweight with one or more bodyweight-related complications, or hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease, and at least one self-reported dietary bodyweight loss effort

Exclusion criteria:

  • Self-reported bodyweight change >5 kg within the last 90 days
  • Previous or planned surgery for bodyweight loss
  • Glycated hemoglobin (HbA1c) ≥6.5% 

Principal Findings:

The primary outcome, mean bodyweight change from baseline, was -15.1% in the semaglutide group vs. -2.4% in the placebo group (p < 0.0001).

Secondary outcomes:

  • Percentage of participants who reached bodyweight reductions of ≥5%: 85% in the semaglutide group vs. 26% in the placebo group (p < 0.0001)
  • Adverse events: 92% with semaglutide vs. 86% with placebo

Interpretation:

Among patients with overweight/obesity without diabetes, oral semaglutide improves weight loss over 68 weeks. Semaglutide was associated with more adverse events compared with placebo. Future trials will need to determine if semaglutide improves cardiovascular outcomes among patients with overweight/obesity without diabetes.

References:

Knop FK, Aroda VR, do Vale RD, et al., on behalf of the OASIS 1 Investigators. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet 2023;Jun 25:[Epub ahead of print].

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Hypertension, Sleep Apnea

Keywords: Body Weight, Dyslipidemias, Glucagon-Like Peptide 1, Hypertension, Metabolic Syndrome, Obesity, Overweight, Primary Prevention, Sleep Apnea, Obstructive, Weight Loss


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