Evidence mapPaperPMID 39495140Full record

Trial reportDiabetes, obesity & metabolism2025

Non-clinical and first-in-human characterization of ECC5004/AZD5004, a novel once-daily, oral small-molecule GLP-1 receptor agonist.

Amina Z Haggag, Jianfeng Xu, Laurie Butcher, Sandra Pagnussat, Graeme Davies, Sara Lundqvist, Wenyu Wang, Natalie Van Zuydam, Karin Nelander, Aruni Jha and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05654831 (A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, First-Time-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05654831 phase1completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, First-Time-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorEccogeneRan2022 to 2023Enrolled69ConditionsType 2 Diabetes MellitusArmsPlacebo, ECC5004
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. The evolving landscape of obesity pharmacotherapy.Nature reviews. Drug discovery · 2026
    Review
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Amina Z HaggagAnaheim Clinical Trials LLC, Anaheim, California, USA.
Jianfeng XuEccogene Inc., Cambridge, Massachusetts, USA.
Laurie ButcherEccogene Inc., Cambridge, Massachusetts, USA.
Sandra PagnussatQPS MRA LLC, Miami, Florida, USA.
Graeme DaviesBioscience Metabolism, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Sara LundqvistAssays, Profiling and Cell Sciences, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Wenyu WangData Sciences and Quantitative Biology, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Natalie Van ZuydamData Sciences and Quantitative Biology, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Karin NelanderCardiovascular, Renal and Metabolism Biometrics, Late Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Aruni JhaClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Hongtao YuClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Alessandro BoianelliDMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Bosse LindmarkDMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Anna OllerstamCardiovascular, Renal and Metabolism Safety, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.
Xuefeng SunEccogene (Shanghai) Co. Ltd., Shanghai, China.
Fan WangEccogene (Shanghai) Co. Ltd., Shanghai, China.
Xiaoliang PanEccogene (Shanghai) Co. Ltd., Shanghai, China.
Haihui LiuEccogene (Shanghai) Co. Ltd., Shanghai, China.
Wengang ChenEccogene Inc., Cambridge, Massachusetts, USA.
Jianfeng XuEccogene (Shanghai) Co. Ltd., Shanghai, China.
Kristina WalleniusBioscience Metabolism, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Jingye ZhouEccogene Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-8767-3878

Funding

Eccogene and AstraZeneca
6 · The paper itself

Abstract

aimsGLP-1 receptor agonists (GLP-1 RAs) are proven therapies for type 2 diabetes mellitus (T2DM) and overweight or obesity. We performed non-clinical and first-in-human (FIH) evaluation of ECC5004/AZD5004, an oral small-molecule GLP-1 RA. MATERIALS AND

methodsECC5004 was profiled in cell lines overexpressing human GLP-1R, in glucose-stimulated insulin secretion (GSIS) assays in a human β-cell line and non-human primates (NHPs). To evaluate safety, ECC5004 was orally administered to NHPs for 9 months and a phase I, double-blind, placebo-controlled FIH study was conducted. This study evaluated single doses of ECC5004 (1-300 mg) in healthy volunteers, and multiple daily doses (5, 10, 30 and 50 mg) in patients with T2DM for 28 days.

resultsECC5004 bound to the hGLP-1R (IC

conclusionECC5004 engaged the GLP-1R across the therapeutic dose range tested and had a safety and tolerability profile consistent with other GLP-1 RAs, along with a pharmacokinetic profile compatible with once-daily oral dosing. These data support continued development of ECC5004 as a potential therapy for T2DM and overweight or obesity. CLINICAL

trial registrationNCT05654831.

Indexed as

Diabetes Mellitus, Type 2Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsSmall Molecule LibrariesAdministration, OralAdultAnimalsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansInsulin-Secreting CellsInsulin SecretionMacaca fascicularisGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsSmall Molecule LibrariesAZD5004ECC5004GLP‐1GLP‐1 RAobesityoverweightsmall moleculetype 2 diabetes mellitus

Identifiers

PMID39495140
PMCPMC11701199

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.