Oral Semaglutide Shows Improvements in Blood Sugar, Cardiovascular Risk Factors – Drug Topics

Report on the Efficacy of Oral Semaglutide in Obesity Management and its Alignment with Sustainable Development Goals

Introduction: Advancing Global Health Objectives

This report details the findings from the phase 3 OASIS 4 clinical trial (NCT05564117) concerning the use of once-daily oral semaglutide (25 mg) for individuals with overweight or obesity. The outcomes of this research directly support the United Nations Sustainable Development Goal 3 (SDG 3), which aims to ensure healthy lives and promote well-being for all at all ages. Specifically, the trial’s focus on mitigating obesity and its associated non-communicable diseases (NCDs) aligns with Target 3.4, which seeks to reduce premature mortality from NCDs through prevention and treatment.

OASIS 4 Trial: Methodology and Key Endpoints

The OASIS 4 trial was a 72-week study designed to evaluate the efficacy and safety of oral semaglutide compared to a placebo in managing body weight.

• Primary Endpoints:
  1. Relative change in body weight from baseline.
  2. Proportion of participants achieving a body weight reduction of 5% or more.
• Secondary Endpoints:
  • Achievement of body weight reductions of 10%, 15%, or 20% and above.
  • Changes in Body Mass Index (BMI) and waist circumference.
  • Modifications in systolic and diastolic blood pressure.
  • Impact on quality of life.

Key Findings and Contribution to SDG 3: Good Health and Well-being

The trial demonstrated significant clinical benefits for patients receiving oral semaglutide, reinforcing its potential to advance public health outcomes as outlined in SDG 3.

Weight Management and NCD Prevention

• The estimated mean change in body weight was -13.6% for the semaglutide group, compared to -2.2% for the placebo group.
• A significantly higher proportion of patients in the semaglutide group achieved weight loss milestones of 5%, 10%, 15%, and 20%.

Cardiometabolic Health Improvements

The treatment showed marked improvements in several cardiometabolic parameters, which are crucial for preventing NCDs like diabetes and heart disease.

1. Glycemic Control: Notable improvements were observed in hemoglobin A1c (HbA1c), fasting plasma glucose, and fasting serum insulin.
2. Cardiovascular Risk Factors: Participants experienced reductions in C-reactive protein and serum triglycerides, indicating a lower cardiovascular risk profile.

Safety and Tolerability

• Gastrointestinal adverse effects were the most common, reported in 74% of the semaglutide group versus 42.2% of the placebo group.

Supporting Evidence and Broader Implications for Sustainable Development

Further data from the STEP UP phase 3b trial (NCT05646706) on a higher 7.2 mg dose of semaglutide complements these findings, showing that patients achieved target BMI levels and improved cardiovascular risk factors. The development and validation of an effective oral therapy for obesity has broader implications for the SDGs.

• SDG 3 (Good Health and Well-being): By providing a potent tool to manage obesity, this innovation directly contributes to the global fight against NCDs, a primary target of SDG 3. It promotes better health outcomes and enhances the overall well-being of a growing global population affected by obesity.
• SDG 10 (Reduced Inequalities): The availability of an oral formulation, as opposed to an injectable, has the potential to improve treatment accessibility and adherence. This can help reduce health disparities among populations disproportionately affected by obesity and its complications.
• SDG 17 (Partnerships for the Goals): The research and development efforts by pharmaceutical organizations like Novo Nordisk exemplify the critical role of the private sector in partnering to achieve global health goals and advance scientific innovation for public benefit.

Analysis of Sustainable Development Goals in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

1. SDG 3: Good Health and Well-being
   • Explanation: The article is centered on a clinical trial for oral semaglutide, a medication designed to treat overweight and obesity. Obesity is a major risk factor for numerous non-communicable diseases (NCDs), including cardiovascular disease and diabetes. The article explicitly states that the treatment showed “improvements in cardiovascular (CV) risk factors” and “improvements in glycemic parameters.” By focusing on a medical intervention that improves health outcomes, reduces risk factors for chronic diseases, and enhances the “overall well-being” of patients, the article directly addresses the core mission of SDG 3, which is to ensure healthy lives and promote well-being for all at all ages.

2. What specific targets under those SDGs can be identified based on the article’s content?

1. Target 3.4: By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.
   • Explanation: The article details a treatment for obesity, a condition that significantly contributes to premature mortality from NCDs like heart disease and diabetes. The clinical trial’s findings demonstrate the effectiveness of oral semaglutide in managing key risk factors associated with these diseases. The text highlights “improvements in hemoglobin A1c (HbA1c), fasting plasma glucose, and fasting serum insulin,” which are critical for managing diabetes. It also mentions improvements in “C-reactive protein and serum triglycerides,” as well as “blood pressure” and “cholesterol,” all of which are direct risk factors for cardiovascular disease. By providing an effective treatment that mitigates these risks, the research contributes directly to the goal of reducing mortality from NCDs.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

1. Indicators for Target 3.4
   • Explanation: The article provides numerous specific, measurable indicators used in the clinical trial to assess the treatment’s effectiveness. These metrics serve as direct measures of progress in treating obesity and reducing the risk of NCDs.
   • Specific Indicators Mentioned:
     • Relative change in body weight: The article states the primary endpoint included “relative change in body weight,” with a mean change of “-13.6%” for the treatment group.
     • Percentage of body weight loss: It was a secondary endpoint to measure the number of individuals who “achieved body weight loss of 5% or more,” as well as 10%, 15%, or 20%.
     • Glycemic control parameters: The analysis showed “greater improvements in hemoglobin A1c (HbA1c), fasting plasma glucose, and fasting serum insulin.”
     • Cardiovascular risk factors: The article mentions “improvements in cardiovascular (CV) risk factors, such as C-reactive protein and serum triglycerides,” as well as achieving healthy levels of “blood pressure” and “cholesterol.”
     • Anthropometric measurements: Secondary endpoints included “change in body mass index” (BMI) and “change in waist circumference.” The STEP UP trial also aimed for a “waist-to-height ratio of less than 0.53.”

4. Summary Table of SDGs, Targets, and Indicators

Source: drugtopics.com