[Edaily Reporter KIM SAE-MI ] Caregen Co.,LTD.(214370)has been promoting its weight management dietary supplement “Korglutide” as an “oral GLP-1 peptide,” emphasizing that it resulted in an average weight loss of 10.78% in just 12 weeks. The company highlighted its unique selling point as being an oral alternative to injectable GLP-1-based obesity treatments, while also minimizing muscle loss.

Based solely on the published clinical trial data, the weight loss results appear quite strong. However, the meaning behind the company’s claims—such as “10.78% weight loss,” “100% response rate,” and “37% less muscle loss”—needs to be examined more closely. In particular, regarding muscle preservation, discrepancies were found between the company’s explanations and the published data.

“10.78% weight loss in 12 weeks”… Effect relative to placebo is 6.45 percentage points

According to Caregen Co.,LTD. on the 1st, the human clinical trial for Coglutide was conducted over 12 weeks with 100 participants—obese individuals and obese individuals with type 2 diabetes—divided into a Coglutide group and a placebo group, each consisting of 50 participants. The Coglutide group took 100 mg orally per day, and both groups followed a diet and exercise regimen.

The result the company emphasizes most is the average weight loss rate of 10.78%—approximately 9.3 kg—in the Coglutide group. While this represents a significant reduction, the placebo group also lost an average of 4.33%—approximately 3.7 kg—in the same trial. The difference in weight loss rates between the two groups was 6.45 percentage points, or approximately 5.6 kg. Therefore, while “10.78% weight loss over 12 weeks” represents the total weight loss observed in the Coglutide group, it is more accurate to view the additional reduction—compared to the placebo group, which was subject to the same dietary and exercise conditions as the Coglutide group—as 6.45 percentage points.

The response rate is also noteworthy. According to data released by the company, all 50 participants in the co-glutide group lost at least 7.8% of their body weight. Consequently, the rate of achieving at least a 5% weight loss was 100% in the co-glutide group and 14% in the placebo group. The proportion of participants who lost 10% or more of their body weight was also significantly different, at 36% and 0%, respectively. This indicates that efficacy signals were evident not only in the simple average values but also in the proportion of participants who achieved weight loss above a certain threshold.

The co-glutide group also showed superior results in non-weight-related metrics. Body fat mass decreased by an average of 6.65 kg in the co-glutide group, compared to a 2.4 kg reduction in the placebo group. The BMI reduction rates were 10.83% and 3.2%, respectively, and glycated hemoglobin (HbA1c) decreased by 0.9 percentage points in the co-glutide group, whereas it increased by 0.15 percentage points in the placebo group. These results underscore the effectiveness of weight management, as not only body weight but also body fat and metabolic markers moved in the same direction.

“All 50 Participants Lost 5% or More of Their Body Weight”… Astonishing Results, but Detailed Data Is Limited

Given that the results of the clinical trial show a fairly strong signal, the importance of detailed data to validate these findings also increases. However, based on the data disclosed so far, while average changes, some response rates, and statistical significance can be confirmed, the distribution of weight changes by patient, standard deviations, confidence intervals, results by subgroups (obese patients and obese patients with diabetes), the analysis population, and the method for handling missing values are not sufficiently disclosed.

In particular, the finding that all 50 participants in the Coglutide group lost at least 5% of their body weight—with even the participant who lost the least still experiencing a 7.8% reduction—indicates a level of consistency in efficacy that is quite remarkable even for general weight management clinical trials. If the distribution of these figures across the entire trial could be confirmed, it would help assess the reproducibility and consistency of the results.

It is also important to consider that this was a 12-week trial in which half of the 100 participants received Coglutide and the other half received a placebo. Even if these results are meaningful as human clinical trial data evaluating the functionality of a dietary supplement, differences in the study population, design, evaluation variables, and statistical analysis methods must be taken into account before directly equating them with the efficacy of GLP-1 pharmaceutical treatments.

Caregen Co.,LTD. has characterized these results as “powerful weight loss effects on par with GLP-1 injections.” However, experts point out that there are limitations to directly comparing therapeutic effects based solely on absolute weight loss rates from different trials.

“37% Less Muscle Loss”?…Upon Calculation, the Trend Is Opposite

The most puzzling aspect is the figure related to “muscle

preservation

,” which the company highlighted as a distinguishing feature.

According to Caregen Co.,LTD., the change in skeletal muscle mass over 12 weeks was -0.27 kg in the co-glutide group and -0.17 kg in the placebo group. In other words, skeletal muscle mass decreased in both groups, and the absolute decrease was 0.1 kg greater in the co-glutide group than in the placebo group.

However, the company described this as “37% Less Loss.” The problem is that while the published figures do yield a “37%” figure, the direction of the change is actually the opposite.

The skeletal muscle loss in the Coglutide group was 0.27 kg, while that in the placebo group was 0.17 kg. Dividing the difference between these two figures—0.10 kg—by the Coglutide group’s loss of 0.27 kg yields approximately 37%. In other words, the exact opposite is true: “The placebo group’s muscle loss was approximately 37% less than that of the Coglutide group.”

In fact, the actual skeletal muscle loss was 0.27 kg in the co-glutide group, which is greater than the 0.17 kg in the placebo group. Based on these two published figures, an explanation is needed as to how the company arrived at the conclusion that co-glutide resulted in “37% less loss.”

The “2.9% muscle loss” cited by the company is a different concept. If we calculate the proportion of the approximately 9.3 kg of weight lost in the Coglutide group over 12 weeks that is attributable to the 0.27 kg loss of skeletal muscle, it comes to about 2.9%. This means that muscle accounted for a small proportion of the total weight loss. While this could serve as evidence that muscle loss was minimal despite significant weight loss, it does not prove that muscle was preserved better than in the placebo group.

Ultimately, the published results of the human clinical trials for Coglutide show strong signs of efficacy, including reductions in body weight and body fat. However, to interpret these results as being “on par with GLP-1 injectables” or representing a “37% reduction in muscle loss,” additional data beyond the figures disclosed by the company is required.

A biotech industry official stated, “Given that it is difficult to develop even an ‘oral GLP-1’ as a pharmaceutical, it is hard to readily accept the claim that a dietary supplement ingredient can produce this level of weight loss,” adding, “Rather than looking solely at efficacy figures, it is necessary to review the detailed data in the full clinical trial report or scientific papers.”