{"id":"mazdutide","name":"Mazdutide","aliases":["IBI362","LY3305677","GLP-1/glucagon dual agonist","Innovent / Lilly"],"url":"https://lyoresearch.com/compounds/mazdutide","summary":"Mazdutide is a once-weekly GLP-1/glucagon dual agonist developed by Innovent with Lilly. In the 610-person GLORY-1 trial, published in the New England Journal of Medicine in May 2025, it produced 14.8% weight loss at 48 weeks on 6 mg against 0.5% on placebo; a 9 mg dose reached 18.6% at 60 weeks in GLORY-2. China's regulator approved it for chronic weight management on 27 June 2025 and later for type 2 diabetes. It is not approved in the US, EU or UK.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"3 phase 3 RCTs","regulatory_status":"Approved in China only","outcomes":[{"outcome":"Body weight","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"2 phase 3 RCTs","evidence":"GLORY-1, 610 Chinese adults, 48 weeks: −12.0% (4 mg) and −14.8% (6 mg) versus −0.5% placebo; at least 5% loss in 73.5%, 82.8% and 11.5%. GLORY-2, 462 adults, 60 weeks on 9 mg: −18.6% versus −3.0%; 44% lost at least 20%.","references":[{"citation":"Ji L, et al. Once-weekly mazdutide in Chinese adults with obesity or overweight (GLORY-1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2411528","url":"https://pubmed.ncbi.nlm.nih.gov/40421736/"},{"citation":"Innovent. Mazdutide 9 mg achieves up to 20.1% weight loss in Chinese adults with obesity (GLORY-2 topline).","where":"Press release, 19 Nov 2025","url":"https://www.prnewswire.com/news-releases/mazdutide-9-mg-achieves-up-to-20-1-weight-loss-in-chinese-adults-with-obesity-glory-2-study-meets-primary-and-all-key-secondary-endpoints-302620471.html"}]},{"outcome":"Liver fat","grade":"B","grade_meaning":"probable, not settled","effect_size":"large","adverse":false,"human_studies":"Phase 3 sub-analyses","evidence":"Among participants with baseline liver fat above 10%: −66% (4 mg) and −80% (6 mg) versus −5% in GLORY-1; −72% versus +5% in GLORY-2.","references":[{"citation":"Ji L, et al. Once-weekly mazdutide in Chinese adults with obesity or overweight (GLORY-1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2411528","url":"https://pubmed.ncbi.nlm.nih.gov/40421736/"},{"citation":"Innovent. Mazdutide 9 mg achieves up to 20.1% weight loss in Chinese adults with obesity (GLORY-2 topline).","where":"Press release, 19 Nov 2025","url":"https://www.prnewswire.com/news-releases/mazdutide-9-mg-achieves-up-to-20-1-weight-loss-in-chinese-adults-with-obesity-glory-2-study-meets-primary-and-all-key-secondary-endpoints-302620471.html"}]},{"outcome":"Blood glucose (HbA1c)","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"DREAMS phase 3 programme","evidence":"DREAMS-1 and DREAMS-2 in type 2 diabetes met their HbA1c endpoints; approved for glycaemic control in China on that basis. DREAMS-3 reported superiority to semaglutide on HbA1c and weight.","references":[{"citation":"Innovent. Mazdutide received approval from China's NMPA for chronic weight management; DREAMS programme in type 2 diabetes.","where":"Press releases, 2025","url":"https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html"}]},{"outcome":"GI side effects","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"Phase 3","evidence":"Nausea, diarrhoea and vomiting were the most frequent adverse events, mostly mild to moderate; discontinuation for adverse events 2.9% versus 0% in GLORY-2.","references":[{"citation":"Ji L, et al. Once-weekly mazdutide in Chinese adults with obesity or overweight (GLORY-1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2411528","url":"https://pubmed.ncbi.nlm.nih.gov/40421736/"},{"citation":"Innovent. Mazdutide 9 mg achieves up to 20.1% weight loss in Chinese adults with obesity (GLORY-2 topline).","where":"Press release, 19 Nov 2025","url":"https://www.prnewswire.com/news-releases/mazdutide-9-mg-achieves-up-to-20-1-weight-loss-in-chinese-adults-with-obesity-glory-2-study-meets-primary-and-all-key-secondary-endpoints-302620471.html"}]}],"regions":[{"region":"European Union","status":"Not authorised","note":"No EMA application. Products sold online as mazdutide are unauthorised medicines."},{"region":"United States","status":"Not approved; cannot be compounded","note":"Phase 2 in the US. The FDA has warned companies selling 'research' mazdutide for human use; it cannot be compounded."},{"region":"United Kingdom","status":"Unlicensed","note":"No MHRA licence; supply is an offence."},{"region":"Australia","status":"Unapproved","note":"Not on the ARTG; prescription-only substance with no lawful supply."},{"region":"Canada","status":"Not authorised","note":"No DIN."},{"region":"Sport (WADA)","status":"Not on the list","note":"Approved by China's NMPA, so S0 does not apply; not named in any section. Athletes should check the annual list."}],"faq":[{"q":"Is mazdutide approved?","a":"In China, yes — for chronic weight management since 27 June 2025 and for type 2 diabetes since later that year. Nowhere else. In the US, EU, UK, Australia and Canada it is an unapproved drug."},{"q":"How does mazdutide compare with tirzepatide?","a":"No head-to-head trial exists. GLORY-2's 18.6% at 60 weeks on 9 mg sits between semaglutide's and tirzepatide's own trial results, but cross-trial comparison is unreliable — different populations, durations and placebo responses."},{"q":"Can I buy mazdutide online?","a":"Not legally outside China, and the FDA has specifically named it in warning letters to research-chemical sellers. What arrives in a vial is unverified."}],"references":[{"cite":"Ji L, et al. Once-weekly mazdutide in Chinese adults with obesity or overweight (GLORY-1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2411528","url":"https://pubmed.ncbi.nlm.nih.gov/40421736/","note":"610 adults, 48 weeks."},{"cite":"Innovent. Mazdutide 9 mg achieves up to 20.1% weight loss in Chinese adults with obesity (GLORY-2 topline).","where":"Press release, 19 Nov 2025","url":"https://www.prnewswire.com/news-releases/mazdutide-9-mg-achieves-up-to-20-1-weight-loss-in-chinese-adults-with-obesity-glory-2-study-meets-primary-and-all-key-secondary-endpoints-302620471.html","note":"462 adults, 60 weeks; topline, not yet peer-reviewed."},{"cite":"Innovent. Mazdutide received approval from China's NMPA for chronic weight management; DREAMS programme in type 2 diabetes.","where":"Press releases, 2025","url":"https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html","note":"Approval 27 June 2025."},{"cite":"Mazdutide: first approval.","where":"Drugs, 2025","url":"https://link.springer.com/article/10.1007/s40265-025-02249-y","note":"Regulatory summary."}],"last_reviewed":"2026-09-03","literature_searched_to":"2026-09-03","changelog":[{"date":"2026-09-03","note":"Initial publication from GLORY-1 (NEJM), GLORY-2 topline and the NMPA approvals."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}