Mazdutide vs CagriSema
It is a weekly weight-loss shot approved in China. Two trials in over 1,000 adults there showed about 15% weight loss, but no US trial has finished. A weekly weight-loss shot that combines two hormones. Large trials show about 20% weight loss over 68 weeks, but it is not yet approved.
Both sit at grade A: strong human evidence. Neither is FDA approved.
Evidence
AStrong human evidence
AStrong human evidence
Human studies cited
Animal or cell studies cited
Why the grade
Mazdutide has completed multiple phase 3 randomized placebo-controlled trials in China: GLORY-1 in 610 adults with overweight or obesity and GLORY-2 in 461 adults with obesity, plus the DREAMS trials in type 2 diabetes, and it won two approvals on that basis. That meets the A definition. The limits are that nearly all trial participants were Chinese, no cardiovascular outcomes trial has reported, and US data are limited to one phase 2 trial of 179 people.
Two large phase 3 randomized placebo-controlled trials support the weight-loss use: REDEFINE 1 randomized 3,417 adults with overweight or obesity and REDEFINE 2 randomized 1,206 adults with type 2 diabetes, both over 68 weeks. A thorough QT study (105 participants) and a phase 2 trial of cagrilintide alone round out the human data. What is missing is regulatory approval and long-term outcome data beyond 68 weeks.
FDA
In clinical trials
Not approved by the FDA for any use. Mazdutide is approved in China, where the NMPA cleared it in June 2025 for chronic weight management in adults with overweight or obesity and in September 2025 for glycemic control in type 2 diabetes. In the US it is investigational, with Eli Lilly holding the rights, one US phase 2 trial published and no phase 3 result or FDA filing reported.
In clinical trials
CagriSema is not approved by the FDA for any use as of 2026-10-26. Novo Nordisk reported submitting it to the FDA for weight management, and the application is under review; no product name has been approved.
Sold for
Mazdutide is pitched as the next step after tirzepatide: a weekly dual agonist that adds glucagon receptor activity to GLP-1 for more weight loss and liver fat reduction, and it is already being sold by gray-market peptide vendors in the US.
CagriSema is talked about as the next step after semaglutide: a weekly injection combining two hormones that early company statements suggested could beat tirzepatide on weight loss.
Studies say
Two phase 3 trials in more than a thousand Chinese adults produced about 15 percent weight loss versus placebo over 48 to 60 weeks and led to approval in China, which grades A, although no US trial has finished and no outcomes trial exists.
Published phase 3 trials show roughly 20% body-weight loss over 68 weeks against 3% on placebo, which earns an A for the weight-loss use, but the head-to-head trial against tirzepatide missed its primary goal.
Class
GLP-1 / glucagon dual agonist
Amylin + GLP-1 combination
Route
Injection
Injection