Lilly has initiated two Phase 3 clinical trials, which include 114 domestic obese patients, signaling a competitive landscape with Novo Nordisk and Hanmi Pharmaceutical in the development of obesity treatments.

While being a latecomer in the GLP-1 field, Lilly is attracting attention by undertaking large-scale clinical trials targeting both obese individuals with and without diabetes. The oral administration aspect of their treatment is noteworthy in a market already populated by GLP-1 treatments, positioning them as a notable contender.

[관련 기사 = 릴리 국내 비만환자 114명 포함 임상3상 2건 착수…노보·한미와 경쟁구도 전망]

It is expected that the trend of GLP-1 (Glucagon-like peptide-1) based obesity treatments, which originated in the United States, will continue in South Korea as well.

Firstly, Lilly Korea has received approval from the Ministry of Food and Drug Safety for two Phase 3 clinical trial plans (IND) of Eli Lilly's LY3502970. LY3502970 (Olfoglypron) is an orally administered GLP-1 receptor agonist. The clinical trials include two indications: one focusing solely on obesity and overweight individuals, and the other on individuals with Type 2 Diabetes (T2D) who are also obese or overweight.

The Phase 3 clinical trial targeting obese patients without diabetes involves investigating the efficacy and safety of once-daily oral LY3502970 compared to a placebo in overweight adults with obesity or weight-related comorbidities. The total number of clinical trial participants is 3,042, with plans to recruit 66 Koreans. The expected completion date for the clinical trial is July 2027.

The primary evaluation variable (endpoint) is the average percentage change in weight compared to the baseline (Week 72), and the treatment duration is 3.5 years. There are a total of four intervention groups: one placebo group and three experimental groups, each receiving different doses of Olfoglypron.

Another Phase 3 trial for LY3502970 conducted by Lilly targets obese patients with Type 2 Diabetes (T2D) as the indication. Similar to the obesity trial, this clinical trial also investigates the efficacy and safety of once-daily oral LY3502970 compared to a placebo, using a random assignment and double-blind approach (ATTAIN-2). The trial aims to recruit a total of 1,500 participants, including 48 Koreans. Just like the obesity trial, this trial also consists of four intervention groups. The primary evaluation variable is the average percentage change in weight compared to the baseline (Week 72). The treatment duration for this trial is shorter than the Phase 3 trial targeting non-diabetic obese patients, spanning 18 months, with an expected completion date in June 2025.

Prior to this, in late June, the GIP·GLP-1 receptor agonist "Mounjaro" (ingredient name: tirzepatide) obtained domestic product approval as a diabetes treatment. While the approval was granted for diabetes indication, it is anticipated that Mountauro, similar to Saxenda, will be used more frequently for obesity treatment as a non-reimbursable option. In the case of diabetes, there are already many cost-effective drugs available from different classes that are covered by insurance. Moreover, due to resistance towards injectable therapies and other factors, diabetes prescriptions are not as commonly administered.

Unlike Saxenda and Mounjaro, the drug being pursued by Lilly for Phase 3 clinical trials stands out due to its oral administration. Additionally, these trials focus exclusively on a large-scale clinical study involving 'obese' patients without diabetes. Despite being a later entrant, there are predictions of rapid growth in the future, considering these unique features.

Amid the rapid influx of global companies introducing GLP-1-based obesity treatments in the domestic market, Hanmi Pharmaceutical, a South Korean pharmaceutical company, is also joining the worldwide trend by venturing into the development of GLP-1-based obesity treatments. The company plans to develop an obesity treatment that utilizes their proprietary platform technology, ‘Labscovery’, with their candidate substance 'Efpeglenatide'.

This treatment is designed for once-a-week administration. To achieve this, on the 28th of last month, they submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for Phase 3 clinical trials. Following regulatory approval, they intend to expedite the process of commercial development.

by Min-ji Seo