Investigational / not FDA-approved

Mazdutide

Dual GLP-1 / glucagon receptor agonist (IBI362 / LY3305677) — China NMPA labeled for weight and T2D; not US/EU FDA-approved.

Editorial review:

What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. Mazdutide (developmental codes IBI362 / LY3305677) is a dual GLP-1 and glucagon receptor agonist. PubChem CID 167312357; formula C207H317N45O65 / MW ~4476; CAS 2259884-03-0. China NMPA has approved mazdutide for chronic weight management in adults with overweight or obesity and for glycemic control in adults with type 2 diabetes (company/NMPA announcements, 2025). Those are China-labeled product–use pairs. They do not equal a US/EU FDA label. Status on this page remains Investigational / not FDA-approved for US readers. Outside that China-labeled framing, treat papers as investigational unless a paper is explicitly about the China-approved object. Mazdutide is not retatrutide, not survodutide (same dual class, different molecule), and not dulaglutide, semaglutide, or tirzepatide.

Bottom line

PubMed holds phase 1/2 Chinese programs and phase 3 obesity (GLORY) and type 2 diabetes (DREAMS) reports. Mark China weight vs China T2D vs earlier dose-finding. A GLORY weight paper is not a DREAMS glycemic paper. A dulaglutide comparator arm is not proof that mazdutide equals dulaglutide for every use. US/EU labeled use is not established in this drawer.

Papers

China-labeled object context — obesity / overweight (GLORY)

PMID 40421736 — Ji 2025 (GLORY-1)

Tested: once-weekly injectable mazdutide versus placebo for body weight in Chinese adults with obesity or overweight (phase 3; NEJM report).

Does not show: a US/EU labeled obesity claim, or a type 2 diabetes primary claim (see DREAMS papers).

PMID 42251595 — Gao 2026 (GLORY-2)

Tested: higher-dose once-weekly mazdutide versus placebo for weight reduction in Chinese adults with obesity (GLORY-2 randomized clinical trial).

Does not show: interchangeability with the GLORY-1 dose object, or a non-China population result.

China-labeled object context — type 2 diabetes (DREAMS)

PMID 41407859 — Zhu 2026

Tested: once-weekly injectable mazdutide versus placebo for glycemic control in Chinese adults with type 2 diabetes (phase 3; Nature report).

Does not show: an obesity-without-diabetes GLORY claim, or a US/EU T2D label.

PMID 41407860 — Guo 2026

Tested: once-weekly injectable mazdutide versus once-weekly dulaglutide in Chinese adults with type 2 diabetes (phase 3 comparator trial).

Does not show: that mazdutide and dulaglutide are the same object, or a weight-management label substitute for GLORY.

Earlier clinical development (pre–phase 3 confirmatory set)

PMID 34430840 — Ji 2021

Tested: multiple ascending doses of once-weekly IBI362 (LY3305677) versus placebo in Chinese adults with overweight or obesity (randomized, placebo-controlled early clinical study).

Does not show: the later GLORY phase 3 obesity object by itself.

PMID 35750681 — Jiang 2022

Tested: once-weekly IBI362 (LY3305677) in Chinese patients with type 2 diabetes (phase 1b randomized controlled trial).

Does not show: the later DREAMS phase 3 glycemic object by itself.

PMID 36247927 — Ji 2022

Tested: higher once-weekly mazdutide (IBI362) dose cohorts versus placebo for safety and efficacy in Chinese adults with overweight or obesity.

Does not show: a confirmatory phase 3 substitute for GLORY-1/GLORY-2.

PMID 38092790 — Ji 2023

Tested: once-weekly mazdutide versus placebo in Chinese overweight adults or adults with obesity (phase 2 randomized controlled trial).

Does not show: the phase 3 GLORY population/result as identical to this phase 2 object.

PMID 37943529 — Zhang 2024

Tested: once-weekly mazdutide versus placebo for efficacy and safety in Chinese patients with type 2 diabetes (phase 2).

Does not show: the phase 3 DREAMS object by itself, or a China weight-management claim.

Secondary synthesis

PMID 38440786 — Nalisa 2024

Tested: systematic review and meta-analysis of randomized trials of mazdutide for weight loss among diabetic and non-diabetic patients.

Does not show: a new primary trial, or a US/EU label.

What is not established

A US/EU approved obesity or type 2 diabetes indication in this drawer. Interchangeability of mazdutide with retatrutide, survodutide, dulaglutide, semaglutide, or tirzepatide. That a China-labeled pair authorizes use of a non-trial or non-approved preparation elsewhere. GLORY weight ≠ DREAMS glycemic as a single undifferentiated claim.

Selected sources

34430840 35750681 36247927 38092790 37943529 40421736 42251595 41407859 41407860 38440786

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