Korean company Caregen claimed that its self-developed glucagon-like peptide-1 (GLP-1) based health functional food showed greater weight loss effects than the obesity treatment injection Wegovy after just 12 weeks of consumption. In particular, it noted that muscle loss, a significant side effect of existing GLP-1 obesity drugs, was also greatly reduced.
Chung Yong-ji, CEO of Caregen, said at a meeting held at Oakwood Premier in Gangnam, Seoul, on the 29th, “About 60% of those who were receiving GLP-1 injections have stopped due to side effects,” and added, “You can effectively lose weight without injections by taking one capsule a day as a nutritional supplement.”
Caregen explained that its self-developed health functional food “Korglutide” mimics the hormone GLP-1, which suppresses appetite. It said that by mimicking the GLP-1 hormone secreted in the small intestine like Wegovy, it increases satiety and reduces appetite to induce weight loss.
◇“10% weight loss in 12 weeks…effectiveness greater than Wegovy"
Caregen conducted a clinical trial involving 100 patients who were obese or had both obesity and type 2 diabetes in India, giving them 100 mg of Korglutide health functional food once a day for 12 weeks. The company reported that participants lost an average of 10.75% of their body weight (about 9.3 kg).
According to the clinical trials conducted by Denmark’s Novo Nordisk, the group administered Wegovy (2.4 mg) lost 6% during the same period, while the oral GLP-1 obesity drug “Ophoglifron (45 mg)” developed by Eli Lilly in the U.S. recorded an 8% loss in its own clinical trials.
Caregen stated that there was almost no muscle loss, a common side effect of existing GLP-1 obesity drugs, in the Korglutide group. CEO Chung said, “About 71.9% (6.65 kg) of the weight loss was body fat, and muscle loss was only 2.9% (0.27 kg),” noting that this represents a groundbreaking improvement compared to the 15-40% level of muscle loss seen with existing GLP-1 obesity drugs.
However, the results of this clinical trial were only partially disclosed. The company has not announced plans to formally publish the results in an international journal.
◇Industry experts: “Lacks scientific credibility…additional verification needed”
The pharmaceutical industry raised questions about the results of this clinical trial, particularly concerning the accuracy of body composition analysis.
In obesity drug clinical trials, dual-energy X-ray absorptiometry (DEXA), which uses X-rays, is employed to enhance the accuracy of body composition analysis. DEXA is widely used in clinical trials and research as it accurately distinguishes between differences in density of fat, muscle, and bone, ensuring high accuracy.
On the other hand, Caregen used bioelectrical impedance analysis (BIA) equipment, similar to body fat measurement devices commonly seen in gyms. Experts point out that BIA can generate errors based on hydration levels or meals, leading to limitations in accuracy.
There are also scientific controversies regarding the safety of Korglutide. According to Caregen, existing GLP-1 injections have a polymer structure consisting of more than 30 amino acids, raising concerns about side effects, but Korglutide is made of only 7 amino acids, so it poses less bodily burden.
However, a researcher in domestic biopharmaceuticals pointed out that “peptides become more effective and safer as molecular weight increases,” adding, “The claim that lower molecular weight means greater safety is incorrect.” He noted, “Medications undergo long-term clinical trials to verify toxicity and safety, and the assertion that health functional foods are safer than medications lacks scientific credibility.”
◇Claims of new drug-like effects…what is the possibility of being recognized as a health functional food?
Despite the weight loss effects comparable to medication, Caregen developed Korglutide as a health functional food. The industry is questioning this approach. Generally, if weight loss exceeds 5%, it can be approved as an obesity drug.
Caregen stated that the regulatory barriers for health functional foods are lower than for pharmaceuticals, making market entry easier. Furthermore, it claims that even as a health functional food, Korglutide has higher efficacy and safety than existing obesity drugs, making it competitive. However, if Korglutide is indeed effective for weight loss as the company claims, it cannot be categorized as a health functional food.
In such cases, the Korean Ministry of Food and Drug Safety or the U.S. Food and Drug Administration would classify it as a medication rather than a health functional food. A Ministry official stated, “According to the Enforcement Regulations of the Act on Health Functional Foods, ingredients that may be mistaken for medications or have disease prevention or treatment effects are not recognized as health functional foods.”
There are ways to reduce the weight loss effect of the product to below 5% or to lower the dosage to be recognized as a health functional food, but it remains uncertain whether this would make it marketable. The industry points out that this could be why Caregen is targeting countries outside major pharmaceutical markets like Korea, the U.S., and Europe.
Caregen announced on the 14th that it has officially registered Korglutide in Lebanon and started its sales. The company plans to expand its sales to countries like Mexico and Ecuador. It also stated it would conduct clinical trials in Italy this year following those in India.
Caregen was founded by CEO Chung Yong-ji in 2001. Since 2022, it has expanded its business areas into blood sugar regulating health functional foods, in addition to aesthetic fields including fat-dissolving fillers. Last year’s revenue was 82.6 billion won, with an operating profit of 34.3 billion won.