EASD 2026 | Ecnoglutide Demonstrates Favorable Safety Profile in Adolescents with Obesity

HANGZHOU, China, Sept. 30, 2026 /PRNewswire/ -- At the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD), Hangzhou Sciwind Biosciences Co., Ltd. ("Sciwind") today announced that its Phase 1b randomized, double-blind, placebo-controlled study of ecnoglutide, the world's first cAMP-biased GLP-1 receptor agonist, conducted in Chinese adolescents with obesity, was accepted as a Late-Breaking Abstract (LBA) at the congress and presented as an oral report.

This study is the first completed clinical trial of a biased GLP-1 receptor agonist in an adolescent population with obesity. Results showed that ecnoglutide was safe and well tolerated in Chinese adolescents with obesity, with pharmacokinetic and safety profiles consistent with those in adults, no unexpected safety signals, and no drug-related serious adverse events during the study; meanwhile, it significantly reduced BMI and body weight and delivered improvements in multiple metabolic parameters¹.

"No Medicine Available": China's Long-Standing Adolescent Weight-Management Treatment Gap

Obesity in children and adolescents is becoming one of China's most pressing public health challenges. According to the World Obesity Atlas 2026 published by the World Obesity Federation, in 2025 China was home to approximately 62 million children and adolescents aged 5–19 with high BMI, including approximately 33 million with obesity—both figures ranking first globally².

Adolescent obesity not only tends to persist into adulthood, but also brings on earlier onset of metabolic complications such as type 2 diabetes, hypertension, dyslipidemia and fatty liver disease, as well as psychological problems including anxiety and low self-esteem; for adolescents with moderate-to-severe obesity, diet control and exercise intervention alone often deliver limited benefit. To date, no anti-obesity medication has been approved for adolescents in China, leaving many children and families without treatment options. For this special population, which is still in a developmental stage, the safety and tolerability of pharmacotherapy are always the foremost prerequisite of concern to parents, physicians and regulators.

Robust Clinical Validation of Ecnoglutide Safety in Adolescents

The study (NCT07143227) is a multicenter, randomized, double-blind, placebo-controlled Phase 1b trial that enrolled 48 adolescents with obesity aged 12–17 years at pubertal Tanner stages 2–5, all of whom had achieved less than 5% BMI reduction after at least 12 weeks of diet control and exercise intervention alone. Participants were randomized 1:1:1:1 to the ecnoglutide 1.2 mg, 1.8 mg or 2.4 mg groups or the placebo group, for a 20-week treatment period. The primary objective of the study was safety and tolerability, and secondary objectives included the assessment of pharmacokinetic and pharmacodynamic parameters.

Study results showed that ecnoglutide was safe and well tolerated across all dose groups in Chinese adolescents with obesity, and no treatment-related serious adverse events occurred during the study. The most frequently reported adverse events were gastrointestinal reactions such as nausea, diarrhea and vomiting, which were mostly mild and transient, and the overall safety profile was consistent with that in the adult population.

The pharmacokinetic (PK) profile of ecnoglutide injection in adolescent participants with obesity was broadly consistent with that observed in adults, with exposure increasing in a dose-dependent manner across the dose groups. The study results support the use of the adult dosing regimen for adolescent weight management and lay the foundation for subsequent larger-scale adolescent clinical development.

Significant Reductions in BMI and Body Weight, with Concomitant Improvements across Multiple Metabolic Parameters

For weight-loss efficacy, ecnoglutide demonstrated rapid and clinically meaningful weight loss in Chinese adolescents with obesity. Body weight reduction was observed as early as Week 4 and continued through Week 20 of treatment. At Week 20, BMI was significantly reduced in all dose groups (−11.2% to −12.6%) compared with placebo (−0.0%), and body weight was also reduced across all groups (−10.4% to −12.1%) versus placebo (+1.2%), with all between-group differences reaching statistical significance (p<0.0001). Body circumference measures such as waist and neck circumference decreased concomitantly, while cardiometabolic parameters including HbA_1c, triglycerides and blood pressure also improved versus placebo, suggesting that ecnoglutide may reduce obesity-related metabolic risk while producing weight loss.

The Biased Mechanism Bolsters Adolescent Weight Management

As adolescents are still growing and developing, safety is especially important: "efficacious and safe" therapy is the core need in weight management, and the biased mechanism is particularly well suited to this sensitive, actively growing population that often requires long-term treatment. Traditional GLP-1 receptor agonists mostly adopt a "full pathway activation" mode: while activating weight-loss signaling pathways, they also often activate pathways associated with gastrointestinal adverse events and receptor desensitization, making it difficult to achieve both potent weight loss and good tolerability. Ecnoglutide optimizes GLP-1 receptor signal transduction through cAMP-biased activation, enhancing metabolic benefits while reducing the activation of unnecessary pathways, thereby providing a mechanistic basis for balancing efficacy and safety.

This mechanistic advantage has been continuously validated in a number of previous adult clinical studies. In the present adolescent study, the safety and tolerability characteristics of ecnoglutide are mutually corroborated by the adult evidence, marking the steady extension of Sciwind's clinical development in the field of weight management from adults to the adolescent population.

Building on the positive results of this Phase 1b study, the Phase 3 clinical trial of ecnoglutide for adolescent obesity has now been initiated and is advancing. Professor Junfen Fu, principal investigator at the Children's Hospital, Zhejiang University School of Medicine, stated: "In the treatment of adolescent obesity, safety always comes first. In the Phase 3 study, with a larger sample and a longer treatment period, we will further confirm ecnoglutide's efficacy and safety, and systematically assess its effects on adolescent growth and development and on metabolic markers such as blood glucose, blood lipids and liver function. We expect that solid data will help bring safe, effective weight-loss medicines to children as early as possible."

Dr. Hai Pan, Founder and CEO of Sciwind Biosciences, stated: "Treatment options for adolescent obesity have long been absent in China, and children and their families have an urgent need for safe and effective weight-loss medicines. We are honored that the first adolescent clinical study of ecnoglutide could be presented at EASD and shared with international peers in the form of a Late-Breaking Abstract. The safety, efficacy and multiple metabolic benefits demonstrated by ecnoglutide in obese adolescents aged 12–17 in this study also give us greater confidence in advancing clinical development in the adolescent population. From adults to adolescents, Sciwind will continue to be guided by rigorous clinical evidence and remain committed to scientific translation, turning the cutting-edge science of the biased mechanism into tangible health benefits for Chinese adolescents with obesity and for more patients with metabolic diseases as early as possible."

About Ecnoglutide

Ecnoglutide injection, originally discovered and developed by Sciwind Biosciences, is the world's first approved cAMP-biased GLP-1 receptor agonist enhancing clinical efficacy and accessibility. Ecnoglutide injection has currently been approved for two indications in China: adult weight management with overweight or obesity and the treatment of adult type 2 diabetes. From Phase I through Phase III, Ecnoglutide injection has consistently demonstrated a favorable safety profile and strong efficacy, with the findings published in leading metabolic journals, underscoring its potential as a promising therapy for patients with metabolic diseases.

About Sciwind Biosciences

Sciwind Biosciences is a commercial-stage biopharmaceutical company, dedicated to addressing the unmet medical needs in the field of weight management and metabolic diseases. Sciwind has established a robust pipeline anchored by the lead asset, ecnoglutide (XW003). It has developed multiple proprietary technology platforms, including biased agonist discovery platform, long-acting and oral peptide delivery platforms, and has identified a series of drug candidates based on these core technology platforms. Sciwind has built an extensive pipeline targeting GLP-1 and synergistic pathways, offering both injectable and oral treatment solutions to deliver sustainable and high-quality therapies for patients with metabolic diseases.

References

SOURCE Hangzhou Sciwind Biosciences Co., Ltd.