Mazdutide is a modified peptide developed as a therapeutic agent studied in the context of weight management and type 2 diabetes. Its characteristic feature is the simultaneous interaction with two receptor systems: the glucagon-like peptide 1 (GLP-1R) receptor and the glucagon receptor (GCGR).
This combination distinguishes mazdutyd from substances that activate only one of these receptors. It is also referred to in scientific literature as IBI362 and LY3305677 [1].
Unlike many experimental peptides whose activity was primarily studied in laboratories, mazdutyd was evaluated in numerous randomized clinical trials involving humans, including Phase 3 studies.
The available results provide significant evidence of weight reduction and improvements in selected glycemic control parameters in specific groups of adults.
However, this does not mean that all proposed metabolic effects, long-term safety in any population, or the efficacy of any product offered under the name mazdutyd have been confirmed.
In the interpretation of the studies, the applied formulation, the characteristics of the participants, the duration of the observation period, the comparison group, and the method of statistical analysis are of particular importance.
Regulatory status is also important. The approval of a medicinal product in one country does not automatically mean its approval in other countries.
The article discusses the identity of mazdupid, its classification, structure, mechanisms of action, results of the most important clinical studies, and limitations of the available evidence.
What is mazdutyd? Name, synonyms and identity of the substance
Mazdutyd is a specific, chemically modified peptide substance developed as a drug with a metabolic action.
The following names can be found in the literature:
- maddityd;
- mazdutide;
- IBI362;
- IBI-362;
- LY3305677;
- LY-3305677.
These designations refer to the same substance being developed as part of pharmaceutical research, and not to several independent drugs [1].
Mazdutyd was designed based on the oxynomodulin biology, a natural peptide involved in the regulation of metabolic processes.
However, it is not an unmodified form of this hormone.
Structural changes have been introduced into it to affect its pharmacological properties and duration of action [2].
Do IBI362 and LY3305677 mean different substances?
No.
IBI362 and LY3305677 are development codes for Mazdudu.
They may appear in scientific publications, clinical trial documents, and materials related to the development of the drug.
Including all these names helps to find previous studies.
However, this does not mean that a product labeled with one of the codes has been automatically verified as identical to the preparation used in clinical trials.
The name of the substance and the quality certification of a specific product are separate matters.
Is mazdutyd the same as natural oxynomodulin?
No.
Mazdutyd is a modified peptide analog developed using knowledge about oxynomodulin.
Its structure was designed to achieve specific pharmacological properties, including prolonged action [2].
Origin from a natural peptide does not mean identical metabolism, exposure time, or safety profile.
Structural changes require a separate evaluation in pharmacological and clinical studies.
How is mazdutyd identified in substance databases?
The American system of substance identity registration assigns the substance identifier MB76Z4IBZ5 to mazdutyd [3].
Such databases are useful when comparing names, chemical descriptions, and scientific documentation.
However, the entry in the identification database should not be equated with the authorization of the finished medicinal product for marketing.
Even if the registration system uses a term referring to the approved status of an entry, this does not automatically mean that the US FDA will grant permission for the drug to be sold.
Regulatory status of mazdudu – China, USA and other countries
In June 2025, the Chinese National Medical Products Administration (NMPA) announced the approval of mazudid in the form of an injection preparation for a specific use related to weight control in adults [4,5].
The decision concerned the indicated population and was presented in the context of activities involving diet and physical activity.
In September 2025, Innovent also announced the approval of mazdudid in China for use in type 2 diabetes [6].
The second information should be understood as a message from the manufacturer, and not as proof of an independently confirmed registration worldwide.
Is mazdutyd approved worldwide?
No.
The permit issued by the Chinese regulatory authority is valid within the boundaries of its jurisdiction and in accordance with the specified conditions.
This does not mean that the American FDA, the European Medicines Agency, or the national authorities of other countries will automatically approve the product.
The status of a product can also vary depending on the indication, formulation, and patient population.
Therefore, the assessment of the legal status of mazdutydu in Poland requires checking the current registers of the competent regulatory authorities.
Does the inclusion of a substance in a clinical trial mean its approval?
No.
A clinical trial is a stage of evaluation of efficacy and safety.
Even positive results from phase 3 studies are not equivalent to an automatic approval of the drug for marketing.
Similarly, the specific scheme evaluated in the study does not have to correspond to the conditions specified in the approved product description.
Therefore, it is necessary to separate scientific results from regulatory decisions.
How is mazdutyd classified?
Mazdutyd is a chemically modified peptide substance.
Pharmacologically, it is classified as a dual agonist of the GLP-1 and glucagon receptors.
The term „dual agonist” refers to two receptor targets.
This does not mean that the preparation contains a mixture of two separate peptides.
One molecule of mazduid exhibits activity against two types of receptors [3].
Why is the exact combination of receptors important?
Not all substances described as dual agonists act on the same receptor pair.
Different medications can affect different biological systems.
Therefore, the results obtained for another dual agonist should not be automatically attributed to mazdutyd.
A similar overall classification does not imply identical mechanisms of action or the same clinical effectiveness.
Mazdutyd – the most important classification information
| Question | The answer based on the available data |
|---|---|
| Is mazdutyd a peptide? | Yes, it is a modified peptide substance |
| Does it contain two separate medications? | No, one molecule activates two types of receptors |
| Which receptors does it affect? | GLP-1R and GCGR |
| Is it a natural oxynomodulin? | No, it is a modified analogue of it |
| Does the entry in the substance database confirm the registration of the drug? | No, the decision regarding the medicinal product is separate. |
| Does every product labeled IBI362 correspond to the product from the study? | No, identity and quality require independent confirmation |
Molecular structure and chemical composition of mazdutydu
The substance identification database describes mazdutyd as a peptide containing 34 amino acid residues and certain structural modifications [3].
This means that the sequence of unmodified amino acids alone does not represent the full identity of the substance.
The mazdutydu project includes chemical modifications and lipidification, which are elements of its long-acting structure [2].
Why are chemical modifications important?
Modifications can affect the physicochemical properties, the behavior of the molecule in the organism, and the exposure time.
Therefore, a modified peptide cannot be considered equivalent to its unmodified precursor.
The full analytical characterization should take into account the actual structure of the substance, and not just the number of amino acid residues.
Does the consistent name of the product confirm its composition?
No.
The product labeled mazdutyd, IBI362 or LY3305677 is not automatically identical to the material used in clinical studies.
Among others, they have the following meanings:
- confirmation of the identity of the modified molecule;
- analysis of appropriate structural modifications;
- profile of pollutants and degradation products;
- the actual content of the substance;
- properties of the formulations;
- production standards and quality control.
In the case of a finished medicinal product, pharmaceutical requirements regarding its form are also important.
Label compliance does not replace analytical documentation or quality confirmation.
Mazdutyd in clinical trials – what has been shown in humans?
The clinical trial program for mazduid includes phase 2 and phase 3 studies regarding body weight, glycemic control, and treatment tolerance.
The results are more important for evaluating clinical applications than the mechanistic experiments themselves.
At the same time, each study should be analyzed taking into account its population, observation time, comparison group, and statistical methods.
Phase 2 study from 2023 – body mass
A randomized phase 2 study published in 2023 involved 248 adult residents of China with overweight or obesity [2].
The results were evaluated over 24 weeks.
The study provided data on weight reduction and tolerance to mazduid.
Among the reported adverse events, symptoms related to the gastrointestinal tract were prominent.
The results supported the further clinical development of the substance.
However, they did not allow for an independent assessment of the safety of long-term use or the prediction of the response of all patient groups.
GLORY-1 – Phase 3 study on weight control
GLORY-1 involved 610 adults in China.
The observation period included 48 weeks [7].
The researchers analyzed changes in body weight and tolerance to treatment.
What results were obtained at the 32nd week?
In the group receiving the higher of the two tested levels of exposure to mazdutide, the average change in body weight was:
- mazdutyd: −12.55%;
- placebo: +0.45%.
These are changes compared to the initial value in the individual groups.
The two numbers should not be presented as differences adjusted for placebo.
What results were obtained at the 48th week?
At the 48th week, the following was recorded:
- mazdutyd: −14.01%;
- placebo: +0.30%.
The most frequently reported adverse events were gastrointestinal disorders.
Why is the way statistical analysis is performed important?
In GLORY-1, an analytical approach known as the treatment-policy estimand was used.
This assessment method takes into account the results in the specific context of the treatment decision and differs from analyses that estimate the effect of hypothetical continuous use of the substance.
Therefore, the results of different studies should not be compared solely based on the highest percentage of weight reduction.
The group average also does not predict the exact answer of a specific person.
GLORY-2 – results after 60 weeks
The 2026 GLORY-2 publication described 461 participants with obesity who underwent treatment, including some with type 2 diabetes [8].
The observation period was 60 weeks.
How did the body mass change?
The average change in body weight was:
- mazdutyd: −16.65%;
- placebo: −1.50%.
The difference between the groups was −15.15 percentage points.
The result provides important information about efficacy in the studied population.
However, this does not mean that every participant achieved the same reduction in body weight.
What adverse events were reported?
Gastrointestinal problems were frequent.
Discontinuation of treatment due to adverse events was reported in 2.9% participants in the mazudine group and in no participant in the placebo group.
Longer observation periods provide additional information, but do not resolve the issue of the long-term safety of the drug.
The results of GLORY-1 and GLORY-2 should not be directly combined into a single predicted effect.
The studies differed in populations, conditions, and details of the analyses.
Phase 2 study in the United States
A randomized, US Phase 2 study published in 2026 included 179 adults with obesity or overweight without type 2 diabetes [9].
The study expanded the geographic scope of clinical data regarding mazduid.
What results were recorded at week 32?
In the highest group studied, the average change in body weight was:
- mazdutyd: −18.1%;
- placebo: −0.9%.
The results are presented as an efficacy or hypothetical estimand analysis.
Therefore, they should not be treated as directly equivalent to an analysis that takes into account all cases of discontinuation of treatment.
What was the tolerance of the treatment like?
In the highest-studied group, 20% participants experienced discontinuation of treatment due to adverse events.
The main cause was gastrointestinal disorders.
This result shows why the assessment of efficacy should be conducted in parallel with the tolerance analysis.
A high average weight loss effect does not mean that every participant was able to continue the treatment.
DREAMS-1 – metformin and glycemic control in type 2 diabetes
The DREAMS-1 study included 320 adult Chinese residents with type 2 diabetes, in whom diet and physical activity did not provide adequate glycemic control [10].
The researchers evaluated, among other things, changes in hemoglobin glycated HbA1c.
How did HbA1c change?
After 24 weeks, the following was noted:
- the first group of mazdutydu: −1.57 percentage points;
- second group of mazdutydu: −2.15 percentage points;
- placebo: −0.14 percentage points.
The results regarding body weight also spoke in favor of mazdutydu.
Among the frequently reported adverse events were nausea, diarrhea, and decreased appetite.
What does an improvement in HbA1c mean?
HbA1c is an indicator that reflects the average glucose exposure over a longer period of time.
Its improvement is an important result in research on diabetes.
However, it does not constitute independent evidence of a reduction in the number of heart attacks, an extension of life, or the prevention of all complications of the disease.
Such results require separate studies with appropriately defined endpoints.
DREAMS-2 – comparison of mazudid with dulaglutide
731 people who were also receiving oral diabetes treatment participated in the DREAMS-2 study [11].
Mazdutyd was compared with a specific regimen of dulaglutide.
What results were obtained?
After 28 weeks, the publication described the fulfilment of the criteria of non-inferiority and superiority in HbA1c.
A greater reduction in body weight was also observed in the mazdutydu group.
At the same time, adverse events related to the alimentary tract occurred more frequently.
Does DREAMS-2 prove the superiority of mazudide over all GLP-1 drugs?
No.
Direct comparative research provides stronger evidence for a specific comparison than aggregating the results of independent studies.
However, superiority over a specific dulaglutide regimen does not automatically mean superiority over all other drugs, dosages, or patient populations.
Any comparison must be made to the conditions actually being studied.
Laboratory and animal studies on mazducid
In addition to clinical studies, experiments are being conducted on additional biological mechanisms.
The 2025 publication analyzed, for example, cognitive performance and molecular parameters in mice with diabetes [12].
Such studies can provide hypotheses regarding new areas of action of the substance.
However, they do not confirm the effectiveness of mazduid in the treatment of cognitive disorders, dementia, or other neurological diseases in humans.
With regard to weight control and glycemic control, randomized clinical trials provide a more direct source of evidence than pre-clinical experiments alone.
In the case of new, unconfirmed indications, animal observations remain an exploratory stage.
How does mazdutyd work? The mechanism of the dual agonist of GLP-1 and glucagon
Mazdutyd acts on two receptors: GLP-1R and GCGR.
The premise of its development was the use of complementary pathways involved in the regulation of metabolism [2].
What role does the GLP-1 receptor play?
The signaling associated with the GLP-1 receptor participates in the regulation of glucose metabolism and processes related to appetite.
The effect on this system is an important component of the pharmacology of metabolic drugs.
However, this does not mean that all substances that activate the GLP-1R have identical clinical properties.
The structure of the molecule, additional receptor targets, exposure, and tolerance are important factors.
What role does the glucagon receptor play?
The glucagon receptor is involved in the regulation of metabolic processes.
In the case of mazdutydu, its activation is part of a designed dual-action mechanism.
However, it is not possible to determine the exact contribution of each receptor to the observed weight reduction solely based on the final results of the study.
Appropriately designed mechanistic experiments would be needed to make such a distinction.
Does action on two receptors mean the sum of two independent effects?
No.
The body's response is the result of the interaction of many physiological pathways.
It cannot be calculated by simply adding the actions of GLP-1 and glucagon.
The actual clinical effect requires direct measurements.
Studies of metabolism show that the effectiveness of a substance can be assessed even when not all the details of its mechanism have been fully elucidated.
Does weight loss mean only the loss of fat tissue?
No.
Total body mass includes various components.
The mass measurement alone does not allow determining which part of the change relates to adipose tissue and which to other components.
Claims regarding the protection of muscle mass or the selective reduction of fat require appropriate body composition studies.
Does improving glycemia mean protection of the cardiovascular system?
This cannot be assumed automatically.
The improvement in HbA1c is an important metabolic result, but it does not replace the measurement of cardiovascular events.
To demonstrate a reduction in the incidence of heart attacks or other serious events, studies designed to assess such outcomes are needed.
Similarly, changes in laboratory markers do not automatically confirm protection against organ dysfunction.
Limitations of the studies, safety, and the most important gaps in the evidence
Differences between populations
A significant portion of the clinical data comes from studies conducted in China.
A smaller Phase 2 study from the United States is also available.
Populations differ in body mass, incidence of diabetes, concomitant treatment, and qualification criteria.
Results regarding specific groups of adults should not be automatically extrapolated to children, pregnant women, breastfeeding women, or patients excluded from the studies.
Limited time of observation
Observation periods ranging from several months to about a year provide important information.
However, they do not allow for a full assessment of the safety of long-term treatment, the durability of changes after discontinuation of therapy, or the frequency of rare and delayed adverse reactions.
Different endpoint points
Weight change, fat mass, non-fat mass, HbA1c, cardiovascular events, and quality of life are not the same parameter.
A positive result from one measurement does not automatically confirm an improvement in all the others.
Why can't the largest percentages of weight loss be directly compared?
Studies vary in terms of observation time, participant characteristics, treatment conditions, and statistical analysis methods.
Some analyses take into account discontinuation of treatment, while others estimate the hypothetical effect of continuing it.
Comparing the percentages themselves can lead to conclusions that no study has directly verified.
DREAMS-3 – why the research project is not a result of effectiveness?
A document describing the project and the initial characteristics of the DREAMS-3 study, which includes a planned comparison with semaglutide, has been published [13].
The publication regarding the project is not, however, a report on the effectiveness results.
Based on this data, it is not possible to determine which medication proved to be more effective.
To reach such a conclusion, real results of a properly conducted comparison are needed.
Adverse events and discontinuation of treatment
In the clinical trial program, symptoms from the gastrointestinal tract regularly appeared.
Their frequency is not the only factor that matters; the severity, duration, and impact on the possibility of continuing treatment are also important.
An event defined as mild or moderate may still affect daily functioning.
Results regarding discontinuation of treatment should be presented together with data on efficacy.
Product quality and regulatory restrictions
The results of clinical studies refer to specific preparations and manufacturing conditions.
They do not automatically confirm the identity, content, integrity, stability, or pollutant profile of independent products sold under the same name.
Similarly, the approval of a drug in one country does not constitute a guarantee of the quality of any product offered in another country.
What issues require further research?
The most important questions are about:
- long-term safety;
- the durability of changes in body weight;
- outcomes after completion or change of treatment;
- effectiveness compared to other medicines;
- cardiovascular events;
- rare adverse reactions;
- populations insufficiently represented in previous studies.
These gaps do not invalidate the clinical results regarding body weight and HbA1c.
However, they set the limits for the proposals that can currently be formulated.
Most frequently asked questions about mazdutyd
1. Does mazdutyd mean a specific substance?
Yes. Mazdutyd is a specific, chemically modified peptide substance, also known by the codes IBI362 and LY3305677. However, this does not mean that every product labeled with this name is identical in terms of composition, quality, and pharmaceutical properties. The identity of the substance, the formulation, and the regulatory status require separate verification. It is also necessary to distinguish the active substance registered in the database from the finished medicinal product.
2. What do the available studies on mazdutydem confirm?
Randomized clinical trials confirm a reduction in body weight and improvements in selected glycemic control parameters in specific adult populations [7,10]. However, they do not confirm all the proposed metabolic benefits, unlimited safety, or the quality of independent products. The strongest conclusions apply to specific indications, groups of participants, and the formulations studied. The improvement in HbA1c is not an automatic indicator of cardiovascular protection, and the decrease in body weight does not by itself indicate changes in body composition.
3. Are IBI362 and LY3305677 different drugs?
No. These are developmental names associated with mazdutid, and not designations of two separate substances [1]. Knowing them makes it easier to find previous publications and clinical trial documents. However, the common name on the product label does not confirm its actual composition. Identifying the name is the first step in the evaluation, not proof of pharmaceutical equivalence.
4. Does the dual agonist mean that mazdutyd contains two peptides?
No. The term „dual agonist” describes the activity of one molecule on two types of receptors. In the case of mazduid, these are the GLP-1 receptor and the glucagon receptor [1]. This is not a mixture of two separate peptides. The distinction is important because a similar term is also used for other drugs that act on different combinations of receptors.
5. Is mazdutyd identical to natural oxynomodulin?
No. Mazdutyd is a designed analog of oxynomodulin, not its unmodified form [2]. Structural changes are an element of the design intended to influence pharmacological properties and duration of action. The natural origin of the biological concept does not imply identical metabolism or lack of adverse effects. The properties of the modified compound require separate studies.
6. Does the entry of mazdutydu in the US substance database mean approval by the FDA?
No. An entry in the identification database serves to describe and identify the chemical or biological substance [3]. It is not equivalent to permission to place a finished medicinal product on the market. The status of the medicinal product must be checked in the current registers of the relevant regulatory authority. Differentiation is of particular importance when assessing the legal availability of products.
7. Does the approval of mazduid in China apply in other countries as well?
No. The decision of the Chinese regulatory authority concerns its jurisdiction and the specified conditions [4]. It does not mean automatic approval of mazduid in Poland, the European Union, or the United States. The product’s status in a given country requires checking the current documents of the relevant regulator. The permit may also specify a specific formulation, indication, and patient population.
8. Were all the mazdutydu studies conducted in China?
No. In 2026, the results of an American Phase 2 study involving adults without type 2 diabetes were also published [9]. This expands the geographic scope of the available data. However, this does not mean that the results can be automatically generalized to all populations. The criteria for eligibility, concomitant treatment, observation time, and the method of analyzing the results still matter.
9. Does the average weight reduction from the study allow predicting the outcome of a particular person?
No. The average describes the response of a group of participants and does not show the full range of individual results. Initial characteristics, tolerance, adherence to study conditions, and other factors can influence the course of treatment. The clinical result represents an estimate of the effect under specific conditions, not a guarantee of identical change in each patient.
10. Does weight loss mean the loss of only fat tissue?
No. Body mass includes fat tissue, muscle, water, and other components. The measurement of mass alone does not allow for differentiation between changes in individual components. Claims regarding selective fat reduction or preservation of muscle mass require body composition testing. Therefore, the result regarding total mass should not be presented as evidence of changes in specific tissue without appropriate measurements.
11. Does the improvement in HbA1c indicate a reduction in the number of heart attacks?
No. HbA1c is a glycemic control parameter, not a direct measure of cardiovascular events. Studies on diabetes confirm improvements in certain glycemic outcomes [10]. To demonstrate a reduction in the incidence of heart attacks or other serious events, appropriate clinical studies with such endpoints are needed. A favorable metabolic marker does not replace direct clinical evidence.
12. Is mazdutyd more effective than all other medications used in weight control?
Such overall superiority has not been demonstrated. The DREAMS-2 study compared specific regimens of mazudine and dulaglutide in people with type 2 diabetes [11]. The result of this comparison does not create a universal ranking of all drugs, populations, and treatment times. Wider conclusions require additional direct comparative studies that include efficacy and safety.
13. Why do different studies report different percentages of weight loss?
Because the participants, observations, the conditions studied, protocol compliance, and statistical methods differ, some analyses include cases of treatment discontinuation, while others estimate the outcome of hypothetical continuation. Direct comparison of the highest percentage values may lead to unwarranted conclusions. It is always necessary to check which parameter and method of analysis was used in a given publication.
14. Are gastrointestinal side effects always minor?
No. Even events classified as mild or moderate can affect daily functioning and lead to discontinuation of treatment. In a US phase 2 study, a significant proportion of discontinuations were reported in the highest-studied group [9]. The assessment of tolerability should include the frequency, severity, duration, and consequences of the events. Safety results are just as important as the average effectiveness.
15. Does the mazdutydu product labeled as investigational has a confirmed clinical efficacy?
No. The name alone does not confirm the pharmaceutical equivalence with the product used in clinical trials. An independent product requires separate verification of identity, content, impurities, shelf life, and stability. The clinical results refer to specific materials and study conditions. They cannot be automatically transferred to unverified products offered by independent retailers.
16. Do cognitive test results in mice confirm the use of mazudide in neurology?
No. The results regarding cognitive functions and molecular parameters in mice with diabetes are preliminary [12]. They may indicate directions for further research, but they do not confirm efficacy in the treatment of dementia or other neurological diseases in humans. Such applications would require clinical trials involving appropriate diagnoses and direct measurements of neurological outcomes.
17. What are the most important questions that require further research on mazdutydem?
The most important issues concern long-term safety, the durability of effects after changing or discontinuing treatment, efficacy compared to other drugs, and results in populations insufficiently represented in previous studies. Data on rare adverse events and direct cardiovascular outcomes are also needed. Current studies provide significant evidence regarding body weight and glycemia, but they do not resolve all possible applications.
Conclusions
Mazdutyd is a specific, chemically modified peptide substance that acts as a dual agonist of the GLP-1 and glucagon receptors.
Randomized clinical trials provide significant evidence regarding weight reduction and improved glycemic control in specific adult populations.
Chinese regulatory decisions confirm the approved uses of mazduid within the boundaries of this jurisdiction.
However, this does not mean automatic approval in other countries or confirmation of the effectiveness of all proposed uses.
Correct interpretation of the results requires a distinction between body weight, body composition, HbA1c, clinical events, and treatment tolerance.
The type of statistical analysis, the characteristics of the participants, and the quality of the product under study also remain important.
Further studies should clarify the long-term results, the durability of the effects, safety, and effectiveness compared to other treatment methods.
Educational, medical and regulatory reservations
The article is of a purely scientific and educational nature. It presents the results of published studies and information regarding regulatory decisions. It does not constitute individual medical advice, diagnosis, or recommendations for the use of mazdutide.
It does not contain instructions for dosage, preparation, administration, injection techniques, or the combination of mazduid with other substances.
Mazdutyd is a pharmaceutical substance subject to country-specific regulatory requirements. Approved indications, product characteristics, and availability may vary between countries and change over time.
The approval of a product in China does not mean its automatic approval by the FDA, the EMA, or the competent authority of another country.
The average results of clinical studies do not allow predicting the response of a particular patient. Safety, contraindications, interactions, and the appropriateness of treatment depend on the individual clinical situation and the specific product.
Preparations marketed under the names mazdutyd, IBI362 or LY3305677 should not be automatically considered equivalent to materials used in studies in terms of identity, content, purity, quality or regulatory status.
Individuals requiring treatment for obesity, diabetes, or other diseases should receive care from appropriately qualified medical personnel. This article does not replace professional care or official information about an approved medicinal product.
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