LY-3549492: An Investigational Oral GLP-1 Receptor Agonist for Metabolic Diseases

1. Executive Summary

LY-3549492 is an investigational small molecule drug candidate under development by Eli Lilly and Company. Administered orally, it is positioned as a potential treatment for Type 2 Diabetes Mellitus (T2DM) and obesity/overweight.[1] Based on available information, LY-3549492 functions as a Glucagon-like peptide-1 receptor (GLP-1R) agonist, placing it within the incretin mimetic class of therapeutics.[2] This mechanism involves mimicking the action of the endogenous GLP-1 hormone to improve glycemic control and promote weight loss.[3]

The highest stage of clinical development currently reported for LY-3549492 is Phase 2, with an active (though not recruiting) trial focused specifically on weight management in adults with obesity or overweight (NCT06683508).[2] Several Phase 1 trials have been completed, including studies in healthy volunteers (NCT06194500) and participants with T2DM (NCT05327595), likely assessing safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).[2] A Phase 1 trial in Japanese participants with T2DM and healthy Japanese individuals (NCT06869018) is planned, indicating global development interest.[2]

The development of LY-3549492 as an oral small molecule represents a potentially significant advancement in a therapeutic area currently dominated by injectable peptide-based GLP-1R agonists. However, detailed efficacy, safety, preclinical findings, and specific intellectual property information are not available in the reviewed sources, making the forthcoming results from the Phase 2 trial critical for assessing its therapeutic potential and competitive positioning.

2. Introduction

Eli Lilly and Company is developing LY-3549492, an investigational drug candidate targeting metabolic diseases.[2] Its emergence occurs within a dynamic therapeutic landscape increasingly shaped by the success of incretin-based therapies. Glucagon-like peptide-1 receptor (GLP-1R) agonists, and more recently dual GIP/GLP-1R agonists like Lilly's own tirzepatide (Mounjaro®, Zepbound®), have demonstrated significant efficacy in managing T2DM and inducing substantial weight loss, transforming treatment paradigms.[3]

A key distinguishing feature of LY-3549492 is its formulation as an oral small molecule.[2] The vast majority of currently marketed and late-stage pipeline incretin mimetics are peptide-based molecules requiring subcutaneous injection.[15] An effective oral agent could offer substantial advantages in terms of patient convenience, potentially overcoming administration barriers associated with injections and broadening patient access. Furthermore, small molecules often possess different manufacturing characteristics compared to complex peptides, which could influence scalability and production considerations.[20] Lilly's parallel development of another oral small molecule GLP-1RA, orforglipron, underscores a strategic commitment to exploring this modality.[20]

This report aims to synthesize the available information on LY-3549492, covering its drug profile, mechanism of action, clinical development program, pharmacology, regulatory status, and strategic context, based on the provided research materials.

3. Drug Profile

• Name: LY-3549492.[1]
• Synonyms: LY 3549492.[2]
• Developer: Eli Lilly and Company.[2]
• Drug Type: Small molecule drug.[2]
• Route of Administration: Primarily Oral. Clinical trials predominantly utilize oral administration.[6] One source mentions oral solution.[1] Intravenous administration was employed in a specific Phase 1 absolute bioavailability study (NCT06194500) but is not the intended therapeutic route.[1]
• Chemical Structure/CAS Number: Specific chemical structure, systematic chemical name, and CAS number for LY-3549492 are not provided in the available research materials.[2]

4. Mechanism of Action (MoA)

LY-3549492 is identified as a Glucagon-like peptide-1 receptor (GLP-1R) agonist.[2] While some sources list the mechanism as "Unknown" or "Undefined" [5], the specific classification as a GLP-1R agonist in multiple database entries, coupled with its development for T2DM and obesity, strongly supports this mechanism. The discrepancies may stem from earlier database entries before the mechanism was fully disclosed or characterized.

GLP-1R agonists function by mimicking the effects of the endogenous incretin hormone GLP-1.[3] Activation of the GLP-1 receptor triggers several physiological responses relevant to metabolic control:

• Enhances glucose-dependent insulin secretion from pancreatic beta-cells.
• Suppresses inappropriate glucagon secretion from pancreatic alpha-cells.
• Slows the rate of gastric emptying, which helps regulate postprandial glucose excursions.
• Promotes satiety and reduces appetite, likely through actions in the central nervous system, contributing to weight loss.[3]

The development of LY-3549492 as an oral small molecule GLP-1RA is a key strategic element. Unlike the large peptide molecules that constitute most approved and late-stage injectable GLP-1RAs (e.g., semaglutide, liraglutide, dulaglutide, tirzepatide), small molecules offer the potential for oral administration, significantly enhancing patient convenience and potentially improving adherence.[20] This approach aligns with Eli Lilly's broader strategy in the incretin space, as evidenced by their development of orforglipron, another oral small molecule GLP-1RA which has shown positive Phase 3 results.[20] Success with oral agents like LY-3549492 could allow Lilly to capture a larger share of the rapidly expanding T2DM and obesity markets by providing an alternative to injectable therapies.

5. Clinical Development Program

Overview

• Highest Development Phase: Phase 2.[2]
• Target Indications: Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM).[1] Conditions like Diabetes Prevention and Hypertriglyceridemia are listed under the Phase 2 obesity trial (NCT06683508), likely representing comorbidities or exploratory areas within that study population.[6]
• Route of Administration: Primarily Oral.[1]

Clinical Trial Summary

The following table summarizes the known clinical trials for LY-3549492 based on the available information:

NCT ID	Phase	Status	Title / Primary Purpose	Condition(s)	Key Population / Criteria	Sponsor	Snippets
NCT06683508	Phase 2	Active, not recruiting	A Phase 2 Study to Investigate Weight Management With LY3549492 Once Daily Compared With Placebo in Adult Participants With Obesity or Overweight	Obesity, Overweight	Adults (18-75 yrs) with BMI ≥30 or ≥27 w/ comorbidity; Stable weight; Excludes T1/T2DM, childbearing potential females	Eli Lilly & Company	2 (inaccessible)
NCT06869018	Phase 1	Not yet recruiting	A Study to Evaluate Safety, Tolerability, PK, and PD of LY3549492 in Japanese Participants With T2DM and Healthy Japanese Participants	Type 2 Diabetes Mellitus, Healthy Japanese	Japanese participants	Eli Lilly & Company	2 (inaccessible)
NCT05327595	Phase 1	Completed	A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM)	Type 2 Diabetes Mellitus	Adults (18-75 yrs) with T2DM on metformin +/- other OAM; HbA1c 6.5-10.5%; BMI 18.5-45; Excludes childbearing potential females	Eli Lilly & Company	8
NCT06194500	Phase 1	Completed	An Open-label Study of the Disposition and Absolute Bioavailability of [14C]-LY3549492 in Healthy Participants	Healthy Volunteers	Healthy males (35-65 yrs); BMI 20-40	Eli Lilly & Company	2 (inaccessible), 6
W8M-MC-CWMM	Master Protocol	Recruiting	A Master Protocol Study of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight	Obesity, Overweight	Adults with obesity or overweight	Eli Lilly & Company	6
J3H-MC-GZNB	Phase 1	Completed	(Title not provided, associated with NCT05327595)	Type 2 Diabetes	N/A (details likely within NCT05327595 data)	Eli Lilly & Company	5
J3H-MC-GZNC	Phase 1	Completed	(Title not provided, associated with NCT06194500)	Healthy Volunteers	N/A (details likely within NCT06194500 data)	Eli Lilly & Company	5
J3H JE GZNG	Phase 1	Not yet recruiting	(Title not provided, associated with NCT06869018)	Type 2 Diabetes	N/A (details likely within NCT06869018 data)	Eli Lilly & Company	5

PK = Pharmacokinetics; PD = Pharmacodynamics; T2DM = Type 2 Diabetes Mellitus; OAM = Oral Antidiabetic Medication; BMI = Body Mass Index; WOCBP = Women of Childbearing Potential.

Phase 2 Program (Obesity/Overweight - NCT06683508)

The lead clinical study for LY-3549492 is a Phase 2 trial (NCT06683508) focused on weight management.[2] This trial, which is part of a larger master protocol (W8M-MC-CWMM, NCT06143956), is designed as a parallel-group, double-blind, placebo-controlled study evaluating the effects of once-daily oral LY3549492 in adults with obesity or overweight.[2] As of late March/April 2025, the trial status was listed as "Active, not recruiting".[6]

The study aims to enroll 275 participants aged 18-75 years with a Body Mass Index (BMI) of ≥30 kg/m2 or a BMI between ≥27 kg/m2 and <30 kg/m2 plus at least one weight-related comorbidity.[6] Participants must have had stable body weight for three months prior to randomization.[6] Key exclusion criteria include T1DM or T2DM, prior bariatric surgery (with exceptions), recent significant cardiovascular events, history of pancreatitis, and, notably, women of childbearing potential.[6] The exclusion of women of childbearing potential is a significant restriction that could reflect early-stage safety precautions or data limitations for this specific population, potentially influencing enrollment dynamics and the initial generalizability of the findings.

The trial involves five different dose arms of LY3549492 compared to placebo, administered orally over approximately one year (56 weeks).[7] The primary outcome measure is the percent change from baseline in body weight at Week 36.[7] Secondary outcomes include absolute change in body weight (kg), the percentage of participants achieving ≥5% and ≥10% body weight reduction, change in BMI, and pharmacokinetic measures (average concentration of LY3549492).[7] The study began in November 2024 and has an estimated primary completion date in April 2026, with study completion estimated for August/September 2026.[5] The focus on weight management as the primary indication in Phase 2 suggests this may be the lead development pathway for LY-3549492.

Phase 1 Program

Several Phase 1 trials have been conducted or are planned:

• NCT06869018 (Japanese Population): This upcoming trial (planned start May 2025) will assess the safety, tolerability, PK, and PD of multiple ascending doses in Japanese participants with T2DM and healthy Japanese volunteers.[2] This study highlights Lilly's global development approach, addressing potential population-specific differences necessary for regulatory filings in Japan.[14]
• NCT05327595 (T2DM Population): This study, completed in April 2024, evaluated the safety, tolerability, PK, and PD of single and multiple doses in adults with T2DM treated with metformin with or without another oral antidiabetic agent.[5] Conducted in Germany/Europe, its completion suggests foundational safety and PK/PD data in the target T2DM population have been generated, likely informing Phase 2 dose selection, although results have not been publicly detailed in the reviewed sources.[2]
• NCT06194500 (Healthy Volunteers - ADME): Completed in February 2024, this specialized Phase 1 study assessed the absorption, distribution, metabolism, and excretion (ADME) and absolute bioavailability of LY-3549492 using an oral dose alongside an intravenous (IV) dose of carbon-14 ([14C]) radiolabeled drug in healthy male participants.[2] Such studies provide crucial pharmacokinetic data required for regulatory submissions and further development.

Efficacy Findings

No specific clinical efficacy results for LY-3549492, such as mean weight loss percentages or A1C reductions, are available in the reviewed documents.[6] The primary outcome data from the ongoing Phase 2 weight management trial (NCT06683508) are not expected until 2026.[7]

Safety and Tolerability

Safety and tolerability were primary objectives in the completed Phase 1 trials (NCT05327595, NCT06194500) and are being assessed in ongoing/planned studies.[2] However, specific adverse event profiles or detailed safety summaries for LY-3549492 are not provided in the available sources.[9] As a GLP-1R agonist, it is anticipated that LY-3549492 might exhibit class-related side effects, most commonly gastrointestinal issues like nausea, vomiting, and diarrhea.[4] Rare but serious adverse events associated with the class include pancreatitis and a potential risk (based on rodent studies) of medullary thyroid carcinoma.[4] Confirmation of the safety profile of LY-3549492 awaits disclosure of clinical trial data.

6. Pharmacology and Preclinical Data

Pharmacokinetics (PK) and Pharmacodynamics (PD)

Pharmacokinetic and pharmacodynamic properties were assessed in the completed Phase 1 trials (NCT05327595, NCT06194500) and are planned endpoints for the upcoming Phase 1 Japanese study (NCT06869018).[2] PK is also a secondary endpoint in the ongoing Phase 2 obesity trial (NCT06683508).[7] The absolute bioavailability study (NCT06194500) using IV and oral administration of radiolabeled drug suggests comprehensive characterization of the drug's absorption and disposition has been undertaken.[2] However, specific PK parameters (e.g., half-life, bioavailability, metabolism pathways) and PD results (e.g., dose-response relationships for glucose lowering or appetite suppression beyond clinical endpoints) are not detailed in the reviewed materials.

Preclinical Data

The provided sources do not contain specific information regarding the preclinical development of LY-3549492, including in vitro receptor binding affinity/potency, cell-based assay results, or efficacy and toxicology findings from animal models.[1] Contextual information confirms Lilly's extensive preclinical work on other incretin mimetics like orforglipron and tirzepatide.[17] The absence of publicly available preclinical or detailed Phase 1 data for LY-3549492 is common for assets in highly competitive therapeutic areas, suggesting Eli Lilly is maintaining data confidentiality during these development stages. Foundational data necessary for advancing to Phase 2 has presumably been generated internally.

7. Regulatory Status and Intellectual Property

Regulatory Designations and Approval Status

There is no information in the reviewed sources indicating that LY-3549492 has received any special regulatory designations from the FDA (e.g., Fast Track, Breakthrough Therapy) or the EMA (e.g., PRIME).[6] The drug is currently investigational and has not received marketing approval from any regulatory agency.[2] It is actively in Phase 2 clinical development.[2]

Intellectual Property (Patents)

The existence of patents covering LY-3549492 is indicated, with one database mentioning "100 Patents (Medical)" associated with the drug, though access to specifics requires login credentials.[2] No specific patent numbers, application details, patent families, or expiration dates related to LY-3549492 were identified in the publicly accessible portions of the reviewed documents.[2] The development of novel oral small molecule GLP-1R agonists occurs within a highly competitive intellectual property landscape, where securing robust patent protection for composition of matter, formulations, and methods of use is critical.[48] The mention of numerous associated patents suggests active IP management by Eli Lilly for this asset.

8. Strategic Context and Conclusion

LY-3549492 represents a strategic effort by Eli Lilly and Company to expand its portfolio in the lucrative metabolic disease market, specifically targeting obesity and T2DM.[1] Its key differentiating feature is its status as an orally administered small molecule GLP-1R agonist, offering a potential alternative to the prevalent injectable peptide therapies.[2] This aligns with Lilly's broader strategy, which includes the development of another oral GLP-1RA, orforglipron, indicating a significant investment in non-injectable incretin mimetics.[20]

The progression of LY-3549492 into a Phase 2 trial focused on weight management (NCT06683508) marks a critical step in its development.[2] The successful completion of foundational Phase 1 studies, including ADME/bioavailability assessments, provides the necessary groundwork.[2] The planned Phase 1 trial in Japan further supports a global development strategy.[2]

However, the ultimate potential of LY-3549492 remains contingent on the outcomes of the ongoing Phase 2 trial. Crucial data regarding its efficacy in inducing weight loss, its safety and tolerability profile compared to both placebo and potentially other GLP-1RAs (though not a direct comparator in this trial), and its pharmacokinetic characteristics will be necessary to establish its competitive profile.

This report is based solely on the information contained within the provided research snippets. Significant data gaps exist concerning detailed preclinical findings, specific Phase 1 results (PK/PD, safety), efficacy data from any trial, and concrete intellectual property details. Therefore, while LY-3549492 holds promise as part of Lilly's next wave of oral metabolic therapies, a comprehensive assessment of its potential awaits the public disclosure of more substantive clinical data.

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