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Summary of the White Paper: Uncovering Insights: Tapping into APAC's Potential for Obesity Clinical Trials

Core Content

This white paper provides an in-depth analysis of obesity prevalence, diagnosis, management, and clinical trial experience across ten Asia Pacific (APAC) countries. It aims to assess the feasibility and potential of APAC investigative sites for conducting obesity clinical trials, considering local practices, investigator credentials, and patient pathways.

Main Objectives

• To gather epidemiological and demographic data on obese and overweight patients in the APAC region.
• To analyze and interpret variations in obesity management and clinical trial practices across APAC countries.
• To evaluate the potential of APAC investigative sites for obesity clinical trials.
• To present real-time data on site feasibility and anticipated challenges.

Methodology

• A cross-sectional online survey was conducted from 18 Oct 2024 to 20 Nov 2024.
• The survey targeted 10 APAC countries: Australia, India, Indonesia, Malaysia, New Zealand, Pakistan, Philippines, Singapore, South Korea, Thailand, and Vietnam.
• A total of 171 sites were contacted, with a target of at least 5 responses per country.
• 138 completed questionnaires were received (81% response rate).
• The survey included 22 questions covering epidemiology, patient pathway, diagnosis, management, and clinical trial experience.

Key Findings

Investigator Credentials and Experience

• The survey was completed by 138 sites across 10 APAC countries.
• 55% of investigators were from the private sector, 22% from both private and public, and 18% from the public sector.
• 70% of investigators had more than 10 years of experience in the therapeutic area.
• The top specialties involved in obesity management were general practitioners, endocrinologists, internal medicine specialists, and cardiologists.

Epidemiology

• Adult patients were the majority in newly diagnosed cases, with adolescents and pediatric patients being less represented.
• Female patients constituted 60–70% of the obese and overweight population, except in India, Australia, and New Zealand, where the gender distribution was more balanced.
• Common comorbidities included diabetes mellitus, hypertension, and dyslipidaemia, as well as obstructive sleep apnoea and osteoarthritis.

Patient Pathway

• 70% of patients visited general practitioners or family physicians directly.
• 30% of patients were referred to specialists.
• Common referring specialties included general practitioners, family physicians, cardiologists, and pulmonologists.

Diagnosis

• The most common method for evaluating obesity was Body Mass Index (BMI), used by 93% of sites.
• Waist circumference (WC) and waist-hip ratio were also widely used (73% of sites).
• Other tools included DEXA (26%), skin-fold caliper (14%), and MRI (9%).
• Some sites in Australia and New Zealand used body composition analyzers, CT scans, and bioelectrical impedance measurement.
• BMI cutoffs varied by country, with some using Asian standards (≥23 kg/m² for overweight, ≥25 kg/m² for obesity) while others followed WHO guidelines (≥25 kg/m² for overweight, ≥30 kg/m² for obesity).

Management and Treatment

• Lifestyle modification was the most common initial approach, used by ~52–83% of patients across most countries.
• Alternative therapies like herbal medications were used by a small percentage, with higher prevalence in the Philippines and Indonesia among women.
• Anti-obesity drugs included semaglutide (28%), liraglutide (25%), and orlistat (22%).
• Phentermine-topiramate was most common in New Zealand, while liraglutide was prevalent in South Korea and Vietnam.
• Reimbursement status varied: all 6 drugs were approved in Australia, India, Malaysia, New Zealand, Pakistan, Philippines, and South Korea. Only orlistat, semaglutide, and liraglutide were approved in Indonesia and Vietnam, and phentermine-topiramate, semaglutide, and liraglutide in Thailand.
• Weight loss success of ≥5% was achieved by about 50% of patients in most countries, with Indonesia and South Korea showing higher success rates (80–89%).
• Common side effects included gastrointestinal issues, insomnia, depression, and headaches, depending on the drug used.
• Patient concerns were primarily related to cost (46%), adverse events (33%), and availability (21%).

Bariatric Surgery

• Only 2–14% of patients had undergone bariatric surgery across APAC countries.
• The most common reason for bariatric surgery referral was morbid obesity (75% of sites).
• Other reasons included obesity-related complications (64%) and failure of medical treatment (63%).

Follow-up Visits

• Monthly follow-ups were the most common (31% of sites), followed by every 3 months (25%).
• Some sites in Australia and New Zealand recommended follow-ups every 6 months or annually.

Clinical Trial Experience

• All participating investigators were interested in conducting obesity clinical trials.
• Every investigator had experience in at least one clinical trial, with 12% having experience in more than 4 trials.
• The main barriers to recruitment included:
  • Stringent inclusion/exclusion criteria.
  • High frequency of follow-up visits.
  • Concerns over adverse events.
  • Accessibility of the site.
  • Frequent lab and imaging requirements.
  • Concerns over efficacy.
  • Investigator concerns about medication compliance.
  • Financial issues and lack of motivation.
• Once enrolled, patients typically completed the trial, with an estimated 5% loss to follow-up.

Discussion Highlights

• Obesity is a growing public health concern in the APAC region, with significant prevalence in countries like Australia, New Zealand, and Malaysia.
• The WHO BMI cutoffs are widely used in obesity trials, but lower BMI thresholds are adopted in some APAC countries due to the higher cardiometabolic risk in Asians at lower BMI levels.
• Clinical staging criteria (e.g., EOSS, CMDS, AACE, KOSC) are increasingly used to assess obesity-related complication risk and guide treatment intensity.
• Lifestyle modification is the primary approach, but long-term adherence remains a challenge.
• Pharmacotherapy is recommended for patients with BMI ≥30 or ≥27 with comorbidities, depending on the country.
• Alternative therapies and herbal medicines are not widely adopted, with limited evidence supporting their efficacy.
• Bariatric surgery is not commonly used due to low prevalence and high cost.
• The pipeline for obesity treatments is robust, with 106 clinical programs and 84 drugs in development, dominated by GLP-1 receptor agonists.

Conclusion

• The APAC region has a significant obesity burden, with high prevalence in several countries.
• Investigator experience and infrastructure are strong, but recruitment challenges persist due to strict trial criteria and patient-related concerns.
• Adoption of country-specific protocols and local BMI cutoffs can help improve trial recruitment and relevance.
• BMI alone is insufficient for evaluating obesity; complementary tools like waist circumference and clinical staging systems are essential for a more accurate assessment.
• Pharmacotherapy and lifestyle modification are the main pillars of obesity management, with the need for long-term strategies and personalized care.

Key Takeaways

• BMI cutoffs vary across APAC countries, with some using lower thresholds due to higher cardiometabolic risk.
• Clinical staging systems are gaining traction to better assess obesity-related complications.
• Lifestyle modification is the first-line approach, but pharmacotherapy is increasingly recommended for long-term management.
• Investigator experience is high, but recruitment challenges remain due to trial design and patient compliance.
• Real-world data and country-specific guidelines are crucial for improving trial feasibility and patient outcomes in the APAC region.