Mazdutide
aka LY3305677 · IBI362
Mazdutide in brief
Mazdutide (LY3305677) is a dual glucagon/GLP-1 receptor agonist developed in China for obesity. Amino Axiom rates its evidence base strong, drawing on 37 PubMed results (23 human studies) and 20 registered trials listed below. Its reported half-life is 7.5–9.5 days (steady-state, SC). It is filed under Weight Loss in the Amino Axiom compound index.
Research data
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Long-form breakdowns
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Overview
Dosing Ranges
Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.
Doses studied in published research. Information presented for research purposes only, not a recommendation for human use.
- Subcutaneous — standard range 4–6 mg, Once weekly. Phase 2/3 obesity and type 2 diabetes programs (e.g. China-based trials including GLORY-1) studied once-weekly SC mazdutide with stepwise titration. Common maintenance arms include 4 mg and 6 mg weekly; lower starting doses and higher exploratory cohorts also appear in the clinical literature.
Half-Life
7.5–9.5 days (steady-state, SC) (high confidence)
Oxyntomodulin-based dual GLP-1/glucagon receptor agonist with fatty-acid modification supporting once-weekly dosing. Human PK from clinical development supports multi-day plasma half-life consistent with weekly SC administration.
Observed Benefits
- Body weight reduction in obesity trials (Strong clinical): Phase 2 clinical trials of mazdutide, a dual glucagon/GLP-1 receptor agonist, reported substantial mean weight reduction in overweight and obesity populations under investigational protocols.
- Glycemic and metabolic parameter research (Moderate clinical): Clinical programs have examined mazdutide for effects on glycemic markers and metabolic endpoints consistent with GLP-1 pathway agonism plus glucagon receptor activity.
- Cardiometabolic and MASH-related research interest (Limited): Investigational indications listed for mazdutide include metabolic dysfunction-associated steatohepatitis and sleep apnea research settings, reflecting dual-agonist metabolic hypotheses still under study.
Side Effects
- Gastrointestinal adverse events — Mild, Common. Nausea, vomiting, diarrhea, and decreased appetite are class-typical findings for GLP-1–pathway agonists and have been reported in mazdutide clinical trial summaries.
- Increased heart rate — Moderate, Uncommon. Glucagon receptor agonism and multi-agonist incretin programs have reported modest heart-rate increases as a research safety signal requiring monitoring.
Contraindications
- Personal or family history of medullary thyroid carcinoma / MEN2 (class-level caution) (Clinical): GLP-1 receptor agonist labeling class carries rodent C-cell tumor findings and related clinical cautions; dual agonists are typically studied under the same exclusion framework.
- History of pancreatitis in trial protocols (Clinical): Incretin-based research programs commonly exclude prior pancreatitis due to class-related safety monitoring requirements.
Storage
Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark
Reconstituted (solution): Refrigerated (2-8°C), 4-6 weeks. Solvent: Bacteriostatic water
Clinical Trials
- NCT04440345 — Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects (PHASE1 / PHASE2), status: COMPLETED. Indications: Overweight or Obesity
- NCT06817356 — A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder (PHASE2), status: ACTIVE_NOT_RECRUITING. Indications: Alcohol Use Disorder
- NCT06931028 — A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2 (PHASE3), status: RECRUITING. Indications: Sleep Apnea, Obstructive, Obesity
- NCT06164873 — A Study of IBI362 9 mg in Chinese Adults With Obesity (PHASE3), status: ACTIVE_NOT_RECRUITING. Indications: Obesity
- NCT02972645 — A Study of LY3305677 in Healthy Participants (PHASE1), status: COMPLETED. Indications: Healthy
- NCT06937749 — A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) (PHASE2), status: RECRUITING. Indications: Metabolic Dysfunction-associated Steatohepatitis (MASH)
- NCT05815680 — A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects (PHASE1), status: COMPLETED. Indications: Overweight Subjects, Obese Subjects
- NCT04904913 — A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects (PHASE2), status: COMPLETED. Indications: Overweight/ Obesity
- NCT03928379 — A Study of LY3305677 in Participants With Type 2 Diabetes (PHASE1), status: COMPLETED. Indications: Diabetes Mellitus, Type 2
- NCT05606913 — A Study of IBI362 in Participants With Type 2 Diabetes (PHASE3), status: COMPLETED. Indications: Type 2 Diabetes
- NCT06184568 — A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity (PHASE3), status: ACTIVE_NOT_RECRUITING. Indications: Type 2 Diabetes, Obesity
- NCT05793450 — Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment (PHASE1), status: COMPLETED. Indications: Renal Impairment
- NCT04466904 — Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM (PHASE1 / PHASE2), status: COMPLETED. Indications: Type 2 Diabetes
- NCT06536023 — This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity (PHASE1), status: COMPLETED. Indications: Adolescents With Obesity
- NCT06124807 — A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight (PHASE2), status: COMPLETED. Indications: Obesity, Overweight and Obesity
- NCT05628311 — A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise (PHASE3), status: COMPLETED. Indications: Type 2 Diabetes
- NCT06143956 — A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight (PHASE2), status: RECRUITING. Indications: Obesity, Overweight
- NCT07255209 — A Study of IBI362 in Chinese Adolescents With Obesity or Overweight (PHASE3), status: RECRUITING. Indications: Adolescents With Obesity or Overweight With Weight-Related Comorbidities
- NCT07083154 — GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study) (PHASE3), status: RECRUITING. Indications: Dementia, Mild, Mild Cognitive Impairment, Type 2 Diabetes
- NCT06862908 — A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity (PHASE2), status: RECRUITING. Indications: Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction