AMG-513: An Emerging Investigational Agent for Obesity

I. Executive Summary

AMG-513 is an early-stage investigational therapeutic agent currently under development by Amgen for the treatment of obesity.[1] This candidate is in Phase 1 clinical trials, signifying Amgen's ongoing strategic commitment to addressing the complex and widespread challenge of metabolic diseases, particularly in the area of weight management.[1] A notable characteristic of AMG-513 at this juncture is its undisclosed mechanism of action, which sets it apart from many other obesity drug candidates that target known biological pathways.[2] This confidentiality, while standard for protecting innovation in early-phase research and development, contributes to both heightened interest and a degree of uncertainty regarding its potential novelty and therapeutic profile.

The cornerstone of AMG-513's current development is a Phase 1 clinical trial, identified as NCT06585462. This study is designed as a randomized, double-blind, placebo-controlled, single and multiple ascending dose investigation. Its primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG-513 in participants diagnosed with obesity.[1] The trial encountered a temporary clinical hold imposed by the U.S. Food and Drug Administration (FDA), which was first reported in early February 2025. Amgen indicated that the reasons for this hold were not directly related to the drug candidate itself. The hold was subsequently lifted by May 2025, enabling the trial to resume participant enrollment.[1] The primary data readout from this pivotal Phase 1 study is anticipated in mid-2026, which will be critical in determining the future development trajectory for AMG-513.[1]

The development of AMG-513, particularly with its unrevealed mechanism, suggests Amgen is pursuing a strategy of diversification within its obesity portfolio. This approach is noteworthy as the company also advances MariTide, a candidate based on GLP-1 agonism and GIP receptor antagonism, through late-stage clinical trials.[1] By exploring multiple biological pathways, Amgen may be aiming to address the multifaceted nature of obesity and mitigate risks associated with dependence on a single therapeutic mechanism in a highly competitive pharmaceutical landscape. The clinical hold, though resolved, adds a layer of scrutiny common in the high-stakes field of obesity drug development, emphasizing the rigorous operational and regulatory hurdles that emerging therapies must navigate.[1]

II. Introduction to AMG-513

AMG-513 is the primary designation for this investigational compound developed by Amgen, Inc..[1] For its ongoing Phase 1 clinical trial, it is associated with Amgen's study identifier 20230022.[6] Amgen, a leading biopharmaceutical company, is responsible for the origination and global development of AMG-513, reflecting its substantial investment in research and development aimed at addressing significant unmet medical needs.[1]

The therapeutic area for AMG-513 is categorized under Endocrinology and Metabolic Disease, with the specific investigational indication being obesity.[1] As of early 2025, AMG-513 is in Phase 1 of clinical development.[1] This status was briefly interrupted by an FDA-imposed clinical hold on its Phase 1 trial (NCT06585462) in February 2025.[1] However, this hold was lifted by May 2025, and the trial has since resumed enrollment, with the most current status reported as "Active - Recruiting" or "now enrolling participants".[1]

Amgen's broader R&D strategy involves significant financial commitment, exemplified by a record $6.0 billion investment in the preceding year, with a focus on pioneering first- or best-in-class medicines.[4] The company strategically employs advanced technologies, including multi-omics (genomics, transcriptomics, proteomics), artificial intelligence (AI), and machine learning (ML), to identify novel drug targets and accelerate the development of innovative therapies.[11] AMG-513's development, particularly given its undisclosed mechanism, is likely a product of these advanced discovery platforms. It stands as an early-stage counterpoint to Amgen's more advanced obesity candidate, MariTide (maridebart cafraglutide), which operates through GLP-1 agonism and GIP receptor antagonism and is progressing into Phase 3 trials.[1]

The continued secrecy surrounding AMG-513's mechanism of action suggests Amgen perceives it as a potentially highly novel therapeutic approach. This strategy allows Amgen to protect its intellectual property and maintain a competitive advantage, especially if the drug targets pathways distinct from the currently prevalent incretin-based therapies. Such an approach could position AMG-513 as a "next-wave" candidate, potentially offering benefits where existing treatments may have limitations or leave unmet patient needs. The clinical hold, while a point of attention, was resolved relatively quickly, implying that the FDA's concerns were likely related to aspects other than immediate human safety signals from the drug itself, such as trial conduct, non-clinical supporting data, or manufacturing processes. The resolution allows Amgen to proceed with generating crucial early human data for this "mysterious" asset.

Table 1: AMG-513 - Key Drug Profile

Feature	Details	Reference(s)
Official Name	AMG-513	1
Other Known Names/Codes	Amgen study ID 20230022	6
Originator/Developer	Amgen, Inc.	1
Therapeutic Area	Endocrinology and Metabolic Disease	3
Investigational Indication	Obesity	1
Highest Development Phase	Phase 1	1
Current Clinical Status	Active - Recruiting (Clinical hold lifted May 2025)	1
Mechanism of Action	Undefined / Not publicly disclosed	2
Drug Type	New Molecular Entity (Specific class unknown)	2

III. Therapeutic Indication: Obesity

The primary therapeutic indication for AMG-513 is obesity.[1] This focus is explicitly demonstrated by the design of its ongoing Phase 1 clinical trial, NCT06585462, which is enrolling "Participants With Obesity".[6] The trial defines this population based on a Body Mass Index (BMI) ranging from ≥30 kg/m2 to ≤40 kg/m2.[7] Interestingly, the clinical trial registration also lists "Diabetes Prevention" as a condition under investigation [10], although the current eligibility criteria for the Phase 1 study exclude individuals with existing diabetes mellitus.

Amgen's commitment to addressing obesity is substantial, recognizing it as a leading global public health crisis affecting over a billion individuals and serving as a significant risk factor for numerous related comorbidities, including cardiovascular disease and type 2 diabetes.[4] This strategic focus is further evidenced by the parallel development of MariTide, another key Amgen asset targeting obesity and its associated health conditions.[1] The broader pharmaceutical landscape is witnessing a surge in anti-obesity drug development, largely propelled by the success of GLP-1 receptor agonists. Within this dynamic environment, companies are striving for differentiation through novel mechanisms of action, improved formulations (such as oral versus injectable), enhanced administration frequency, and more favorable side effect profiles.[13]

The specific BMI range of 30-40 kg/m² chosen for the initial Phase 1 trial of AMG-513 targets a well-defined population with established obesity, according to World Health Organization classifications. This approach excludes individuals who are merely overweight or those with super-obesity, thereby creating a more uniform group for the initial assessment of safety and pharmacokinetics. Such focused enrollment is a standard practice in early-phase clinical development, aiming to minimize confounding variables and enhance the clarity of initial safety signals. Should AMG-513 demonstrate a favorable profile, subsequent, larger trials would likely investigate its effects across a broader spectrum of BMI categories.

The inclusion of "Diabetes Prevention" as a listed condition for NCT06585462 [10], despite the exclusion of participants with active diabetes, is an intriguing aspect. Given that obesity is a primary driver for the development of type 2 diabetes, any effective weight-loss therapy inherently contributes to diabetes prevention. This listing may indicate that Amgen is exploring pharmacodynamic markers related to glucose metabolism and insulin sensitivity within the current study, even in non-diabetic obese individuals. Alternatively, it could signal a long-term strategic interest in formally pursuing a diabetes prevention indication if AMG-513's mechanism of action or observed effects suggest benefits beyond weight reduction alone.

Amgen's strategy of advancing both AMG-513 and the later-stage MariTide underscores a comprehensive effort to secure a significant position in the rapidly expanding obesity market.[1] MariTide, a GLP-1 agonist and GIP receptor antagonist, is being developed with a focus on less frequent dosing (e.g., monthly).[1] AMG-513, with its distinct (though undisclosed) mechanism and current exploration of subcutaneous and intravenous routes in Phase 1 [6], may offer a different therapeutic profile. This dual-candidate approach provides Amgen with multiple opportunities to address the diverse needs of patients with obesity, potentially catering to different efficacy expectations, tolerability concerns, or administration preferences, thereby strengthening its competitive stance in this critical therapeutic area.

IV. Mechanism of Action

A pivotal and defining characteristic of AMG-513 at its current stage of development is that its precise mechanism of action (MOA) remains undefined and has not been publicly disclosed by Amgen.[1] This lack of transparency is noteworthy, particularly in the context of the highly competitive obesity therapeutic landscape.

Amgen executives have maintained a guarded stance, being described as "historically tight-lipped" and "judicious" when it comes to sharing specifics about AMG-513, including its biological target or pathway.[1] This approach is consistent with strategies often employed by pharmaceutical companies during the early phases of drug development to protect novel discoveries and maintain a competitive edge.

The AdisInsight drug profile for AMG-513 explicitly states "Mechanism of Action: Undefined mechanism".[2] Similarly, the Synapse by Patsnap database indicates "Mechanism: -" for this candidate.[3] This consistent reporting across pharmaceutical intelligence platforms underscores the current information vacuum regarding how AMG-513 is intended to exert its effects on weight reduction.

During the period when the Phase 1 trial (NCT06585462) was under an FDA-imposed clinical hold, Amgen representatives communicated that the issues prompting the hold were not believed to be related to the drug candidate itself.[1] This assertion, made while the MOA was (and remains) undisclosed, implies that the regulatory concerns were likely not tied to an inherent problem with the drug's fundamental biological activity or target.

The persistent non-disclosure of AMG-513's MOA strongly suggests that Amgen perceives this candidate as possessing a potentially novel or significantly differentiated approach to obesity treatment. In a field where many existing and pipeline drugs target well-characterized pathways (such as the incretin system), a truly innovative mechanism would represent a valuable asset. Protecting such an innovation during the vulnerable early stages of development is a standard industry practice to secure intellectual property and potential first-mover advantages. This contrasts with many investigational drugs where the general target class or pathway is known even during early clinical phases.

The unknown MOA has significant implications for the future development and market positioning of AMG-513. Without this information, it is challenging for the external scientific and medical community to predict its potential efficacy spectrum, its likely side effect profile, or how it might compare and contrast with established obesity treatments, which are predominantly GLP-1 receptor agonists. If AMG-513's mechanism is indeed novel, it holds the promise of addressing unmet medical needs, potentially benefiting patient populations who do not respond adequately to current therapies, or offering a complementary therapeutic strategy. However, this novelty also carries the inherent risks associated with validating an entirely new biological concept for therapeutic intervention.

The context of the clinical hold is also framed by this undisclosed MOA. Amgen's clear communication that the hold was not drug-related [1] is particularly crucial. Had the MOA been known and considered inherently high-risk, a clinical hold might have been interpreted with greater alarm regarding the drug's safety. The current narrative allows Amgen to maintain that the fundamental biology of AMG-513 is not the source of concern, thereby shifting the focus to other, presumably resolvable, aspects related to trial conduct or supporting non-clinical data packages. The subsequent lifting of the hold lends credence to this position, for the time being. As development progresses, particularly if AMG-513 demonstrates promising results, disclosure of its mechanism will become increasingly important for scientific validation, regulatory review, and eventual clinical adoption.

V. Clinical Development Program: Phase 1 Trial (NCT06585462)

The clinical development of AMG-513 is currently centered on a pivotal Phase 1 study, registered under the ClinicalTrials.gov identifier NCT06585462.[1] This trial represents the first-in-human evaluation of the compound.

A. Trial Design and Objectives

The official title of the study is: "A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity".[6] Amgen also identifies this study with the internal ID 20230022.[6]

This Phase 1 trial [1] incorporates several robust design elements typical for early-phase clinical research. It is a randomized, double-blind, placebo-controlled study, ensuring that neither the participants nor the investigators are aware of who receives the active drug versus an inactive placebo, thereby minimizing potential bias in outcome assessment. The study is structured into two main parts: Part A involves a Single Ascending Dose (SAD) design, and Part B employs a Multiple Ascending Dose (MAD) design.[1] This sequential assignment approach allows for careful escalation of the dose to evaluate safety and tolerability at increasing exposure levels.

The primary objective is to assess the safety and tolerability of AMG-513 following both single and multiple administrations.[6] This is chiefly measured by the "Number of Participants With Treatment-emergent Adverse Events (TEAEs)". The timeframe for this primary outcome assessment is approximately 178 days for Part A (SAD) and 225 days for Part B (MAD).[7]

Secondary objectives focus on characterizing the pharmacokinetic (PK) profile of AMG-513. Key PK parameters to be evaluated include the Maximum Observed Drug Concentration (Cmax​), Time to Cmax​ (Tmax​), and Area Under the Concentration-time Curve (AUC) of AMG-513. These PK assessments are scheduled from Day 1 up to Day 57.[6] Additionally, the study aims to evaluate the pharmacodynamics (PD) of AMG-513, although specific PD markers or endpoints are not detailed in the available information.[6]

The rigorous design of this first-in-human trial, incorporating randomization, double-blinding, placebo control, and careful dose escalation, is essential for generating reliable initial data on the safety and PK profile of AMG-513. This information is fundamental for making informed decisions about subsequent stages of development. The exploration of PK and PD parameters will be critical for understanding the drug's behavior in the human body and for selecting appropriate doses and dosing regimens should AMG-513 advance to Phase 2 studies.

B. Participant Population

The trial aims to enroll approximately 80 participants.1

Key inclusion criteria for participants are:

• Adult males and females aged between 18 and 65 years.[6]
• A Body Mass Index (BMI) between ≥30 kg/m2 and ≤40 kg/m2, consistent with a diagnosis of obesity.[6]
• Female participants must be of non-childbearing potential, a common precaution in early-phase trials before comprehensive reproductive toxicology data are available.[6]

Key exclusion criteria include:

• A history and/or clinical evidence of diabetes mellitus, defined by parameters such as Hemoglobin A1c (HbA1c) ≥6.5% or a fasting plasma glucose ≥126 mg/dL (7 mmol/L) at screening.[6]
• Screening triglyceride levels ≥5.65 mmol/L (equivalent to 500 mg/dL).[6]

These eligibility criteria are designed to recruit a relatively homogenous group of obese individuals without significant confounding metabolic comorbidities like type 2 diabetes or severe hypertriglyceridemia. This approach helps to isolate the effects and safety signals of AMG-513 in its initial human testing phase. While the trial listing includes "Diabetes Prevention" as a condition of interest [10], the exclusion of individuals with existing diabetes suggests that this aspect might be an exploratory focus on relevant biomarkers or a consideration for future development pathways, rather than a primary treatment target in this initial Phase 1 study.

C. Intervention

Participants in the trial are randomized to receive either AMG-513 or a placebo.1

The route of administration for AMG-513 in Part A (SAD cohorts) is either subcutaneous (SC) or intravenous (IV) injection. In Part B (MAD cohorts), AMG-513 is administered via SC injection.6 Placebo is administered via the same routes in the respective parts of the study.

The study design involves ascending doses, meaning that successive cohorts of participants receive increasing amounts of AMG-513. This dose-escalation strategy is standard for Phase 1 trials, aiming to identify the maximum tolerated dose (MTD) or an optimal dose range for further investigation, while closely monitoring for safety.1 The specific dose levels being tested are not provided in the summarized research.

The evaluation of both SC and IV routes in the SAD part of the study allows Amgen to characterize the absolute bioavailability and compare the PK profiles of different administration methods. The selection of SC administration for the MAD part suggests this is the likely intended route for chronic therapeutic use if AMG-513 progresses in development.

D. Current Status and Timeline

The Phase 1 trial NCT06585462 officially commenced on September 09, 2024.1

As of May 2025, the trial is reported to be actively enrolling participants 1, following the lifting of a clinical hold that was imposed by the FDA in early February 2025.1 Amgen has stated that the hold was not related to the drug itself 1, and its resolution allowed for the continuation of the study.1 While some trial registries like AmgenTrials.com had listed "Recruitment Complete" at one point 7, the more recent reports from May 2025 affirm ongoing enrollment.

The estimated primary completion date for the trial, when primary outcome data collection is expected to be finished, is mid-2026.1 The estimated study completion date is July 2026 or July 25, 2026.7

The clinical hold, though temporary, likely introduced a minor delay in the overall trial timeline. However, its relatively swift resolution suggests that the FDA's concerns were adequately addressed by Amgen, allowing the development program to proceed. The mid-2026 timeframe for the primary readout indicates that substantial data on AMG-513's safety, tolerability, and PK profile will become available then, which will be a critical inflection point for decisions regarding further development into Phase 2 trials.

E. Study Locations

The NCT06585462 trial is being conducted at multiple clinical research sites located within the United States.[6] Specific sites identified as recruiting or participating include:

• Anaheim Clinical Trials, Anaheim, California [7]
• Orange County Research Center, Lake Forest, California [7]
• Fomat Medical Research, Oxnard, California [7]
• Orange County Research Center, Tustin, California (status noted as "Site Not Available" in one source, but potentially active) [10]
• Translational Clinical Research LLC, Aventura, Florida [7]
• Clinical Pharmacology of Miami, LLC, Miami, Florida [7] The selection of these U.S.-based, experienced Phase 1 clinical trial units is a common practice for U.S. pharmaceutical companies like Amgen for conducting initial human studies.

Table 2: Clinical Trial NCT06585462 - Core Details

Parameter	Details	Reference(s)
NCT ID	NCT06585462	3
Official Title	A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity	6
Sponsor	Amgen	6
Other IDs	20230022 (Amgen Study ID)	6
Phase	1	1
Status	Active - Recruiting (as of May 2025, clinical hold lifted)	1
Study Start Date	September 09, 2024	7
Estimated Primary Completion Date	Mid-2026	1
Estimated Study Completion Date	July 2026 / July 25, 2026	7
Target Enrollment	Approximately 80 participants	1
Primary Outcome Measures	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	7
Key Secondary Outcome Measures	- Maximum Observed Drug Concentration (Cmax​) of AMG 513 <br> - Time to Cmax​ (Tmax​) of AMG 513 <br> - Area Under the Concentration-time Curve (AUC) of AMG 513 <br> <br> - Pharmacodynamics of AMG 513	6
Intervention Arms	Part A (SAD): AMG 513 (SC or IV) vs. Placebo (SC or IV) <br> Part B (MAD): AMG 513 (SC) vs. Placebo (SC)	6
Key Inclusion Criteria	- Males and females, 18-65 years <br> - BMI ≥30 kg/m2 and ≤40 kg/m2 <br> - Females: non-childbearing potential	6
Key Exclusion Criteria	- Diabetes mellitus (HbA1c ≥6.5% or fasting glucose ≥126 mg/dL) <br> - Triglycerides ≥5.65 mmol/L (500 mg/dL)	6
Locations	United States (multiple sites in CA, FL)	7

VI. Preclinical Data

Specific preclinical data for AMG-513, such as results from in vivo efficacy studies in animal models of obesity or detailed toxicology findings, are not provided in the available research documentation. This absence of public information is typical for investigational drugs in the early stages of clinical development, as companies generally maintain confidentiality over such data until publication or presentation at scientific forums. The data generated during the preclinical phase would have been essential for the Investigational New Drug (IND) application submitted to regulatory authorities like the FDA, which permitted the initiation of the Phase 1 human trial.

While direct preclinical results for AMG-513 are lacking, Amgen's overarching research and development strategy provides some context. The company has publicly emphasized its commitment to leveraging advanced scientific platforms, including human genetics, multi-omics (genomics, transcriptomics, and proteomics), artificial intelligence (AI), and machine learning (ML) in its drug discovery and early development processes.[11] These technologies are employed to identify and validate novel drug targets, design therapeutic molecules, and predict their efficacy and safety with greater precision. Given this strategic focus, it is plausible that the discovery and initial characterization of AMG-513 were informed by these data-driven approaches, potentially leading to the selection of a novel biological target or pathway for obesity that is distinct from more established mechanisms. This aligns with the current non-disclosure of its MOA, which may indicate a unique approach derived from Amgen's sophisticated discovery engines.

VII. Chemical Properties and Formulation

Information regarding the specific chemical properties of Amgen's investigational obesity drug, AMG-513, is limited in the public domain. It is classified as a New Molecular Entity (NME) [2], and its drug type is listed as "Unknown" in some databases, indicating that its precise chemical class has not been disclosed.[3]

The formulation used in the ongoing Phase 1 clinical trial (NCT06585462) involves administration via subcutaneous (SC) or intravenous (IV) injection.[6] This mode of delivery is common for biologic drugs, such as peptides or antibodies, or for certain small molecules that may have poor oral bioavailability or require specific pharmacokinetic profiles achievable through injection. Amgen has considerable expertise in developing biologic therapies, including its other obesity candidate, MariTide, which is an antibody-peptide conjugate.[1] While the injectable formulation of AMG-513 might suggest it is not a traditional oral small molecule, this remains speculative in the absence of definitive chemical structure or MOA disclosure.

It is crucial to distinguish Amgen's investigational obesity drug AMG-513 from other chemical entities that may appear under the same "AMG-513" identifier in public chemical databases. For instance:

• PubChem CID 6102242 refers to "4-amino-N-(5-methylisoxazol-3-yl)benzenesulfonamide; silver".[19] This is a distinct chemical compound and is not the AMG-513 under development by Amgen for obesity.
• ChemSpider ID 9254417 identifies "Methyl 2-amino-3,4-di-O-benzyl-2-deoxy-α-D-glucopyranoside".[20] This, too, is unrelated to Amgen's obesity candidate.
• A patent referenced as US20170037130A1, sometimes linked with "AMG-513" in broader searches, pertains to a bispecific antibody targeting DLL3 and CD3 for small cell lung cancer and is not relevant to Amgen's AMG-513 for obesity.[21]

This disambiguation is critical to avoid misattributing chemical properties, mechanisms, or preclinical data from unrelated compounds to Amgen's investigational drug. The lack of detailed public information on the chemical structure of Amgen's AMG-513 is consistent with its early stage of development and the proprietary nature of such information.

VIII. Future Perspectives

The development trajectory for AMG-513 is currently centered on the outcomes of its Phase 1 clinical trial, NCT06585462. A key milestone will be the primary readout from this study, which is anticipated in mid-2026.[1] This initial data package will provide crucial insights into the safety, tolerability, and pharmacokinetic profile of AMG-513 in humans. These findings will be instrumental for Amgen in deciding whether to advance the candidate into Phase 2 development, where efficacy in inducing weight loss would be more formally assessed.

Should the Phase 1 results be positive, Amgen would likely proceed with designing Phase 2 studies. These studies would aim to establish proof-of-concept for efficacy in obesity, explore different dosing regimens, and further characterize the safety profile in a larger patient population. It is also probable that if AMG-513 shows continued promise, more details regarding its mechanism of action would be disclosed to the scientific and medical communities, as well as to potential investors and partners.

In the broader context of Amgen's obesity pipeline, the company is actively disseminating data on its more advanced candidate, MariTide. For example, new Phase 2 data for MariTide is expected to be shared in June at the American Diabetes Association (ADA) meeting.[1] While these activities pertain to a different molecule, they reflect Amgen's overall commitment to advancing its obesity portfolio and engaging with the scientific community. Amgen has also expressed intentions to explore MariTide for other obesity-related conditions.[1] If AMG-513 demonstrates a favorable profile and a distinct or complementary mechanism, it too could eventually be investigated for a broader range of metabolic indications.

However, as a Phase 1 candidate, AMG-513 is still several years away from potential regulatory approval and market entry. The journey through clinical development is lengthy and subject to high attrition rates. The mid-2026 data readout will, therefore, be a significant inflection point, heavily influencing the future course of this investigational agent. Any early pharmacodynamic signals suggestive of efficacy in weight management or favorable metabolic changes observed in the Phase 1 study would substantially increase interest and confidence in its continued development.

IX. Conclusion

AMG-513 is an early-stage investigational drug candidate being developed by Amgen for the treatment of obesity.[1] Its most distinctive feature at present is its undisclosed mechanism of action, which suggests a potentially novel therapeutic approach in a competitive field.[2] The ongoing Phase 1 clinical trial (NCT06585462) is designed to provide foundational data on its safety, tolerability, and pharmacokinetics in individuals with obesity.[6]

The recent lifting of an FDA clinical hold on this trial is a positive development, allowing Amgen to continue generating essential human data.[1] Amgen's assertion that the hold was not drug-related mitigates immediate concerns about the compound's intrinsic safety, although the event underscores the complexities of early-phase drug development.

As an early-Phase 1 asset with an unknown mechanism, AMG-513 represents a high-risk, potentially high-reward component of Amgen's broader strategy to address the global obesity epidemic. It complements their late-stage candidate, MariTide, by potentially offering a different biological approach to weight management.

The future of AMG-513 hinges critically on the results of the NCT06585462 trial, with the primary readout expected in mid-2026.[1] These data will be pivotal in determining its viability for further development. Positive safety and pharmacokinetic findings, coupled with any encouraging pharmacodynamic signals related to weight or metabolic parameters, would be necessary to justify progression to Phase 2 studies. Until such data become available, and more clarity is provided on its mechanism of action, AMG-513 will remain a subject of cautious observation and anticipation within the medical and pharmaceutical communities. Its development highlights the ongoing search for innovative and differentiated therapies to meet the significant unmet needs in obesity treatment.

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