The prevalence of obesity has been steadily increasing worldwide, leading to a growing demand for effective anti-obesity medications.1 In recent years, clinical trials have focused on developing new drugs with better efficacy and safety profiles. Some of the most promising medications currently in clinical trials include semaglutide, tirzepatide, and setmelanotide which target various mechanisms involved in appetite regulation, glucose metabolism, and energy balance.2
However, one of the challenges in anti-obesity medication clinical trials is ensuring participant adherence to the medication regimen, especially when it comes to self-administration of subcutaneous (SC) injections commonly used to deliver these therapies.3 In this blog post, we will discuss the current trends in clinical trials for new anti-obesity medications and the adherence challenges posed by self-administration of SC injections.4
Current Trends in Anti-Obesity Medication Clinical Trials
Recent clinical trials have focused on developing new anti-obesity medications that can deliver better efficacy, safety, and convenience. In the OASIS 1 trial, Novo Nordisk found that once-daily oral semaglutide 50 mg resulted in superior and clinically meaningful weight loss of 15.1% compared with placebo when used alongside diet and physical activity in adults with overweight or obesity without Type 2 diabetes.5 “Having an oral formulation of semaglutide in addition to the subcutaneous, or injectable, formula available will allow people who struggle to lose weight with diet and physical activity alone to take this effective medication in a way that best suits them,” said Professor Filip K Knop MD, PhD, Gentofte Hospital, University of Copenhagen.6
In Eli Lilly’s recent phase 2 clinical trial of subcutaneous retatrutide lost more than 24% of their starting body weight within 48 weeks of treatment with the highest dose.7 In a second Eli Lilly trial in adults living with obesity and type 2 diabetes, once-weekly subcutaneous tirzepatide 10 mg and 15 mg provided substantial and clinically meaningful reduction in body weight, with a safety profile that was similar to other incretin-based therapies for weight management.8
Another sponsor of a promising early phase study in obesity is using AiCure medication adherence and electronic patient reported outcomes technology to guide and track administration of a biologic with SC injection. The study team is using AiCure Patient Connect, a mobile app used by participants for real time dosing instructions and leveraging computer vision to ensure and predict medication adherence. Learn more by downloading this case study.
Medication Adherence Challenges of Subcutaneous Injection
Although SC injections may be less tolerated than oral treatments, both their efficacy and safety profile seem superior.9 There are several challenges associated with using SC injections in anti-obesity medication clinical trials. These include:
Injection site reactions: SC injections can cause injection site reactions, such as pain, swelling, and redness, which can be uncomfortable for participants and may affect compliance with the medication regimen.10
Adherence to injection schedule: SC injections require participants to adhere to a specific injection schedule, which can be challenging for some individuals and may detract from the effectiveness of the medication.11
Limited access to healthcare: SC injections may require healthcare professionals to administer the medication, which can be a challenge for individuals with limited access to healthcare or who live in remote areas.12
To address these challenges, researchers use various methods to monitor participant adherence during clinical trials, such as participant diaries, site visits, medication counts, and electronic monitoring.4 In the early phase study of obesity using AiCure, the sponsor introduced a hybrid trial design with on-site and remote visits to reduce participant and site burden.
Conclusion
As the field of anti-obesity medication clinical trials continues to evolve, researchers are developing new drugs with improved efficacy and safety profiles. However, ensuring participant adherence to the medication regimen, particularly with self-administration of SC injections, remains a challenge. By addressing these challenges and utilizing innovative technologies such as AiCure Patient Connect, researchers can improve the accuracy and reliability of clinical trial results and ultimately bring more effective anti-obesity medications to the market.
Learn more by reading the AiCure Patient Connect fact sheet.
1Pharmacologic Treatment of Overweight and Obesity in Adults - Endotext - NCBI Bookshelf
2Anti-obesity drug discovery: advances and challenges
3Ibid
4Content powered by Perplexity AI
5Late Breaking Weight Loss Innovations: New Drug Therapies Shown to Offer Positive Outcomes for Obesity and Type 2 Diabetes Management
6Ibid
7Triple–Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial | NEJM
8Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial - The Lancet
9Novel anti-obesity therapies and their different effects | DMSO
10Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site - PMC
11Clinical review of subcutaneous semaglutide for obesity
12Payer Perspectives on Intravenous versus Subcutaneous Administration of Drugs
