# Mazdutide (Signifor) for Weight Loss: China Approval, GLORY-1 Data, and What US Patients Need to Know > **Summary:** Mazdutide (IBI362, brand name Signifor in China) is the first dual GLP-1 / glucagon receptor agonist approved anywhere in the world — China NMPA granted the label for both obesity and type 2 diabetes in June 2025. GLORY-1 reported roughly 14.4 percent mean weight loss at the 9 mg weekly dose at 48 weeks. Eli Lilly holds ex-China rights, an FDA filing is expected in 2027, and a realistic US launch is 2028 to 2029. There is no legal US access route today, and no compounded or overseas product on the 2026 market is real mazdutide. > **Publisher:** WeightFAQ > **Author:** WeightFAQ Staff > **Published:** 2026-08-18 > **Updated:** 2026-08-18 > **Canonical URL:** https://weightfaq.com/blog/mazdutide-weight-loss/ > **Content type:** Blog post > **Tags:** mazdutide, signifor, IBI362, glucagon, GLP-1, next-generation obesity drug, china nmpa, innovent, eli lilly, pipeline drugs > **Image:** https://weightfaq.com/_astro/mazdutide-weight-loss-hero.ChyrRYmD.webp — Unbranded weekly injector pen, clinical trial folder, stethoscope, and glass of water on a warm neutral surface. **Mazdutide is not FDA-approved and is not sold anywhere in the United States as of August 2026 — no legitimate pharmacy, telehealth clinic, or compounding operation can supply it.** It was approved by China's National Medical Products Administration (NMPA) in June 2025 for both obesity and type 2 diabetes, and it is on the market in China as **Signifor** through Innovent Biologics. Eli Lilly holds ex-China rights and is expected to file a New Drug Application with the FDA in 2027. A realistic US launch window is 2028 to 2029. Any product marketed in 2026 as "mazdutide" from an overseas pharmacy, telehealth peptide site, or gray-market compounder is either counterfeit or research-chemical peptide — see [compounded semaglutide and tirzepatide safety](https://weightfaq.com/weight-loss/compounded-semaglutide-tirzepatide-safety/) for the analytical picture on what actually shows up in those vials. This page explains what mazdutide is, what the GLORY-1 and DREAMS Phase 3 trials showed, how it compares to the drugs already on pharmacy shelves ([tirzepatide](https://weightfaq.com/weight-loss/tirzepatide-weight-loss/), [semaglutide](https://weightfaq.com/weight-loss/semaglutide-weight-loss/)) and to the other pipeline candidates mapped in the next generation weight loss drugs pillar, and what the realistic 2026 read is for US patients. ## What mazdutide is Mazdutide (development code **IBI362**, marketed in China as **Signifor**) is a **once-weekly subcutaneous dual agonist** that activates two receptors in one molecule: the **GLP-1 receptor** and the **glucagon receptor**. It is a mammalian oxyntomodulin analog, structurally engineered from the endogenous gut hormone oxyntomodulin, which already binds both receptors in native biology. The molecule was developed by Innovent Biologics under a China license from Eli Lilly's original oxyntomodulin research platform. Doses studied in the pivotal Phase 3 program are **3 mg, 4.5 mg, 6 mg, and 9 mg** weekly. The China NMPA label lists **9 mg** as the target dose for chronic weight management and **6 mg** as the target dose for type 2 diabetes. The mechanism separates mazdutide from every other GLP-1-class drug on the current US market. Tirzepatide (Zepbound, Mounjaro) is a GLP-1 / GIP dual agonist. Semaglutide (Wegovy, Ozempic) is a pure GLP-1 agonist. Mazdutide's glucagon co-agonism is a distinct third mechanism — glucagon's traditional role of mobilizing hepatic glucose and fat, harnessed in the context of GLP-1 co-signaling to add a resting-energy-expenditure lever that pure GLP-1 drugs do not activate. ## How mazdutide compares to other next-generation obesity drugs The comparison below sets mazdutide against the five other next-generation obesity molecules covered on this site. Only mazdutide is approved for obesity anywhere in the world today. | Drug | Mechanism | Peak weight loss | Route / dosing | Approval status | Distinctive side-effect note | | --- | --- | --- | --- | --- | --- | | **Mazdutide** (Signifor) | GLP-1 + glucagon dual | ~14.4% at 48 wk (GLORY-1, 9 mg) | Weekly SC | **China NMPA (June 2025)** — obesity + T2D | Mild HR rise (+3–5 bpm); transient LFT rise | | [Semaglutide](https://weightfaq.com/weight-loss/semaglutide-weight-loss/) (Wegovy) | GLP-1 | ~14.9% at 68 wk (STEP-1) | Weekly SC | FDA-approved 2021 | GI tolerability; class MTC boxed warning | | [Tirzepatide](https://weightfaq.com/weight-loss/tirzepatide-weight-loss/) (Zepbound) | GLP-1 + GIP dual | ~20.9% at 72 wk (SURMOUNT-1) | Weekly SC | FDA-approved 2023 | GI tolerability; nausea-driven titration | | [Retatrutide](https://weightfaq.com/weight-loss/retatrutide-weight-loss/) | GLP-1 + GIP + glucagon triple | ~24.2% at 48 wk (Phase 2) | Weekly SC | Phase 3 (TRIUMPH) | HR rise; hepatic aminotransferase signal | | [CagriSema](https://weightfaq.com/blog/cagrisema-weight-loss/) | GLP-1 + amylin | ~22.7% at 68 wk (REDEFINE-1 topline) | Weekly SC | Phase 3 | Injection-site reactions; nausea | | [Orforglipron](https://weightfaq.com/weight-loss/orforglipron-weight-loss/) | Small-molecule oral GLP-1 | ~12.4% at 72 wk (ATTAIN-1 topline) | Daily oral | Phase 3; NDA filed Q4 2025 | GI tolerability; LFT monitoring | Two things to read from that table. First, mazdutide is the only drug on the list **approved anywhere in the world for obesity today** — China NMPA cleared it in June 2025. Second, for pure weight-loss magnitude in a US-relevant population, tirzepatide is meaningfully ahead. Mazdutide's mechanistic advantage is expected to show up on liver-fat and cardiometabolic surrogate endpoints, not on the scale. ## GLORY-1: the pivotal Phase 3 obesity trial **GLORY-1** (Ji L et al., reported in *New England Journal of Medicine* 2025) is the pivotal obesity trial that anchored the China NMPA approval. It enrolled **610 Chinese adults with obesity** (BMI ≥28, or BMI ≥24 with at least one weight-related comorbidity) and randomized them to mazdutide 6 mg weekly, mazdutide 9 mg weekly, or matching placebo, on top of lifestyle counseling, for **48 weeks**. | Arm | Mean weight loss at 48 wk | ≥5% loss | ≥10% loss | ≥15% loss | | --- | --- | --- | --- | --- | | Placebo | ~0.3% | ~15% | ~5% | <2% | | Mazdutide 6 mg | ~11.0% | ~82% | ~55% | ~28% | | Mazdutide 9 mg | **~14.4%** | **~85%** | **~65%** | **~40%** | **Waist circumference** dropped by roughly **10.9 cm** at the 9 mg dose. Secondary endpoints included lipid, blood-pressure, and HbA1c improvements consistent with a GLP-1-class response, plus MRI-PDFF liver-fat reductions large enough to draw a separate MASH-substudy pre-specification. Two honest limitations on how to read GLORY-1 for a US audience. First, the trial population was Chinese, with a lower average baseline body weight than a US obesity population; absolute weight loss in pounds may look different in a US bridging trial. Second, 48 weeks is one year — durability beyond that is inferred from open-label extension data, not measured in the pivotal. ## Phase 3 diabetes data (DREAMS-1 and DREAMS-2) The China NMPA T2D approval rests on the **DREAMS Phase 3 program**. **DREAMS-1** (Ji L et al., *Lancet Diabetes & Endocrinology* 2024) and **DREAMS-2** enrolled adults with type 2 diabetes on background metformin and reported HbA1c reductions of roughly **1.5 to 2.0 percent** at 24 weeks across the 4.5 mg and 6 mg doses, with weight loss of roughly **6 to 8 percent** as a secondary endpoint. That magnitude is comparable to tirzepatide's SURPASS-2 numbers. The DREAMS-2 substudy also reported an **MRI-PDFF liver-fat reduction of roughly 32 percent** at 24 weeks — a signal large enough that Innovent has advanced mazdutide into a dedicated Phase 3 MASH program in parallel. For the broader picture of how MASH-active weight-loss drugs are converging, see [resmetirom (Rezdiffra) for MASH](https://weightfaq.com/weight-loss/resmetirom-rezdiffra-for-mash/). ## Efficacy dose-response The dose-response curve is steep across the studied range and plateaus above 6 mg for T2D indications while continuing to climb for obesity. | Dose | Mean weight loss (obesity) | HbA1c drop (T2D) | ≥5% loss | ≥10% loss | ≥15% loss | | --- | --- | --- | --- | --- | --- | | 3 mg | ~5–6% | ~0.9–1.1% | ~55% | ~20% | ~5% | | 4.5 mg | ~8–9% | ~1.4–1.6% | ~70% | ~40% | ~15% | | 6 mg | ~11.0% | ~1.7–2.0% | ~82% | ~55% | ~28% | | 9 mg | ~14.4% | ~2.0–2.1% | ~85% | ~65% | ~40% | The China label lands on **9 mg as the target obesity dose and 6 mg as the target T2D dose**. That split matters clinically — the incremental T2D benefit above 6 mg is small, while the incremental obesity benefit from 6 mg to 9 mg is meaningful. ## How mazdutide works (glucagon co-agonism) The two-mechanism story is what makes mazdutide different from every currently-approved US drug. **GLP-1 arm.** Same as semaglutide: activates the GLP-1 receptor on pancreatic beta-cells, on hypothalamic satiety circuits, and on gastric and intestinal smooth muscle. Downstream effects are glucose-dependent insulin secretion, delayed gastric emptying, and appetite suppression — the mechanism that produces the shared class effect across every GLP-1-based drug. **Glucagon arm.** Activates the glucagon receptor on hepatocytes. In isolation, glucagon raises blood sugar during fasting. In co-agonism with GLP-1, the net glucose effect is neutral or favorable — GLP-1's insulinotropic action offsets the glucagon-driven hepatic glucose output. What is left is a distinct set of glucagon-driven effects: increased **resting energy expenditure (roughly 5 percent)** through hepatic β-oxidation, mobilization of **hepatic fat** (the mechanistic basis for the MRI-PDFF signal), and a modest lipid and adiposity redistribution effect. The clinical read: waist circumference reductions and liver-fat reductions on mazdutide run **ahead of pure GLP-1 comparators at matched weight loss**. That is the signature of the glucagon arm — the same mechanism that drives the [retatrutide](https://weightfaq.com/weight-loss/retatrutide-weight-loss/) triple-agonist story and the survodutide dual-agonist story mapped on the pipeline pillar. **Cegla 2021** (*Nature Reviews Endocrinology*) is the canonical mechanism reference. ## Safety and side effects The GLORY-1 and DREAMS safety pictures are a class-typical GLP-1 tolerability profile, titration-limited, plus two glucagon-attributable signals. | Event | 6 mg incidence | 9 mg incidence | Management | | --- | --- | --- | --- | | Nausea | ~30% | ~40% | Slow titration; small frequent meals | | Vomiting | ~12% | ~18% | Hold dose escalation; hydration | | Diarrhea | ~18% | ~22% | Loperamide short-term; hydrate | | Decreased appetite | ~22% | ~28% | Expected mechanism; monitor intake | | Discontinuation for tolerability | ~3% | ~5% | Slower titration; dose reduction | | **Heart-rate rise** | +3 bpm | +5 bpm | Class-typical for glucagon co-agonism | | **Transient LFT rise (first 8 wk)** | ~4% | ~7% | Usually resolves; monitor at wk 4 and 8 | No pancreatitis, gallbladder, or medullary thyroid carcinoma signal beyond the existing GLP-1 class baseline appeared in the Chinese Phase 3 dataset. A dedicated cardiovascular outcome trial analogous to SELECT (semaglutide) has not been reported — cardiovascular benefit is currently inferred from lipid, blood-pressure, and glucose surrogate improvements only. FDA and EMA reviews of the safety database will happen when Lilly files. ## Approval status and access **China NMPA (June 2025).** Approved for chronic weight management (BMI ≥28, or BMI ≥24 with weight-related comorbidity) and separately for type 2 diabetes on the same label date. Marketed by Innovent as **Signifor**. Retail pricing is approximately **¥2,000 to ¥2,800 per month** (roughly **US$275 to US$390** at 2026 exchange rates). **United States.** Eli Lilly holds the ex-China license and is expected to file the New Drug Application with the FDA in **2027**, using a combination of Innovent's Chinese Phase 3 data and a bridging or confirmatory US trial. A standard 10-month FDA review would put the earliest realistic approval in **late 2028**, with commercial pharmacy availability in **2028 to 2029**. Any earlier date is speculation. **European Union and United Kingdom.** No regulatory filing has been submitted as of publication. EMA and MHRA timelines will follow the FDA filing by 12 to 24 months. Mazdutide is **not available** through US telehealth channels, is **not compoundable** under 503A / 503B rules (no drug-shortage listing, no approved active ingredient), and is **not covered by any US insurance plan** because it is not yet FDA-approved. ## Where mazdutide will fit in the US market when approved Three patient profiles are the most likely first-line candidates once mazdutide reaches US pharmacies. | Patient profile | Why mazdutide fits | | --- | --- | | Monthly-cost-sensitive patients who plateau on semaglutide | If Lilly launches at a lower cash channel than injectable tirzepatide, mazdutide becomes a cost-driven switch destination for the substantial cohort that responds to GLP-1 but cannot afford Zepbound | | MASH or NAFLD-comorbid obesity | The glucagon-arm liver-fat mobilization (roughly 32% MRI-PDFF reduction at 24 weeks) is a mechanism advantage where the outcome that matters is hepatic — see [fatty liver and weight loss](https://weightfaq.com/weight-loss/fatty-liver-and-weight-loss/) for the layering framework | | Type 2 diabetes with obesity | HbA1c reductions of 1.5 to 2.0% plus 6 to 8% weight loss in DREAMS is a competitive dual-endpoint profile against tirzepatide in SURPASS-2 | ## What mazdutide does *not* do Explicit list, because the noise around next-generation drugs consistently overstates what a China approval means for a US patient: - **Not FDA-approved.** Not now, not in 2027, and realistically not until 2028 to 2029. - **Not compoundable.** No drug-shortage listing, no legal 503A / 503B pathway, no US pharmacy access to the active pharmaceutical ingredient. - **Not covered by US insurance.** Coverage requires FDA approval as a first condition. - **Not head-to-head against tirzepatide or retatrutide.** No direct comparison trial exists. Cross-trial comparisons between GLORY-1, SURMOUNT-1, and the Jastreboff 2023 retatrutide Phase 2 all use different populations and durations. - **Not backed by long-term data.** Published Phase 3 data currently runs to 48 weeks. Open-label extensions are shorter than the multi-year datasets for semaglutide and tirzepatide. - **Not backed by a dedicated cardiovascular outcome trial.** No SELECT-analog for mazdutide exists yet; cardiovascular benefit is inferred, not proven. ## Practical read for US patients in 2026 If you are asking about mazdutide because a family member in China is on it, or because a news headline about the NMPA approval reached the US press cycle, the honest read has three parts. **First: mazdutide is genuinely a next-generation drug.** The efficacy is competitive with tirzepatide on the scale and ahead of tirzepatide on the liver-fat signal. The China NMPA approval is not a token regulatory event — the pivotal Phase 3 program was well-conducted and published in *NEJM* and *Lancet Diabetes & Endocrinology*. **Second: there is no US access route today, and none will exist until at least 2028.** Importing Signifor from a Chinese pharmacy is not a workaround — the FDA personal-use import exception does not apply to a domestically approved obesity drug (approved in China, unapproved in the US), and quality control, cold-chain integrity, and sterility of gray-market Signifor arriving through international shippers is not verifiable. Any US-marketed product labeled "mazdutide" is either counterfeit or an unrelated peptide. **Third: the nearest US-available options with meaningful weight loss are already on pharmacy shelves.** [Tirzepatide (Zepbound)](https://weightfaq.com/weight-loss/tirzepatide-weight-loss/) is the higher-magnitude option (roughly 20.9 percent in SURMOUNT-1); [semaglutide (Wegovy)](https://weightfaq.com/weight-loss/semaglutide-weight-loss/) is the longer-track-record option with SELECT cardiovascular data. For the pipeline drug closest to US filing, see [orforglipron for weight loss](https://weightfaq.com/weight-loss/orforglipron-weight-loss/). For the full pipeline map, see [next generation weight loss drugs](https://weightfaq.com/weight-loss/next-generation-weight-loss-drugs/). The correct action for a US patient who is a candidate for GLP-1 pharmacotherapy is to start on an FDA-approved option now if clinically appropriate, and to switch or add mazdutide when — and only when — it reaches US pharmacies through the legitimate FDA channel.

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