Mazdutide
Also known as · IBI362 · LY3305677 · GLP-1/glucagon dual agonist (Innovent)
- EvidenceClinical
- CategoryGLP-1 & incretin
- RoutesubQ
- Half-life174.8–1075.7 h (7.3–44.8 days, phase 1b)
01 / Dosing schedule
Cited dosing
Mazdutide is an investigational once-weekly subcutaneous GLP-1/glucagon dual agonist developed by Innovent (licensed from Eli Lilly); it is not FDA approved. Phase 2 trials in Chinese adults published complete week-by-week escalation ladders to 3, 4.5, 6 and 9 mg.
Mazdutide phase 2 obesity trial — once-weekly subQ escalation by week
| Phase | Dose & frequency |
|---|---|
| 3 mg arm | 1.5 mg weeks 1-4, then 3 mg weeks 5-24 |
| 4.5 mg arm | 1.5 mg weeks 1-4, 3 mg weeks 5-8, then 4.5 mg weeks 9-24 |
| 6 mg arm | 2 mg weeks 1-4, 4 mg weeks 5-8, then 6 mg weeks 9-24 |
| 9 mg arm (part 2, BMI >=30) | 9 mg once weekly; escalation reported in the sponsor deck as 3 mg wk 0-4, 6 mg wk 4-8, 9 mg maintenance from wk 8 |
| Treatment period | 24 weeks, then 12 weeks off-treatment follow-up |
Source indication · Overweight and obesity in Chinese adults (Innovent phase 2, published in Nature Communications), plus a phase 1b/2a multiple-ascending-dose study and a 9 mg phase 2 obesity study
- Injection frequency
- Once weekly; 24 weeks in the phase 2 obesity trial (with a 48-week extension for the 9 mg study), 12-16 weeks in the phase 1b/2a cohorts.
- Injection sites
- n.a. — mazdutide was given by subcutaneous injection from prefilled devices; no anatomical site is specified in the phase 2 publication.
02 / Reconstitution
Reconstitution reference
Not applicable: mazdutide and placebo were supplied in prefilled devices in the phase 2 trial, and the sponsor deck describes three pen strengths rather than a reconstituted vial.
03 / Overview
Protocol overview
Mazdutide is a once-weekly GLP-1 and glucagon receptor dual agonist. In the multiple-ascending-dose study, terminal elimination half-life ranged from 174.8 to 1075.7 hours (7.3-44.8 days), which supports weekly administration.
The cleanest published dosing is the phase 2 trial in Chinese adults with overweight (BMI >=24 with hyperphagia or a weight-related comorbidity) or obesity (BMI >=28), excluding anyone with diabetes or HbA1c >=6.5%. 248 participants were randomised in the first part.
Unusually for this class, the phase 2 paper prints the full ladder: the 3 mg and 4.5 mg arms started at 1.5 mg for four weeks; the 6 mg arm started at 2 mg then 4 mg. The higher-dose cohorts in the phase 1b/2a study escalated 3/6/9 mg over 12 weeks or 2.5/5/7.5/10 mg over 16 weeks.
A separate randomised, double-blind, placebo-controlled phase 2 study of 9 mg (n=60 mazdutide, n=20 placebo) enrolled Chinese adults with BMI >=30 without diabetes for 24 weeks with extension to 48 weeks; the sponsor deck describes an 8-week escalation using three pen strengths. Mazdutide is approved in China but is not FDA approved.
04 / References
References
- Ji L et al. Phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nat Commun 2023 ↗
- Mazdutide (IBI362) higher-dose 9 mg phase 2 clinical study in obesity — Innovent Biologics clinical data update ↗
- Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide — multiple ascending doses (PMC9561728) ↗