Evidence map›Paper›PMID 40959944›Full record

Trial reportDiabetes, obesity & metabolism2025

Coated glucose microbeads stimulate enteric hormone release and improve glucose tolerance in Phase 1 and 2 clinical trials.

Kai Deusch, Arthur Deboek, Christian Sina, Coral Capo-Velez, Vivianette Alicea, Stephan Duller, Susanne Grafe, Darcy Lidington, Julia Hanchard, Steffen-Sebastian Bolz

3 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
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 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT05713773 phase1completednot on this map

Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads Formulations After Single-dose Administration (Fasting Conditions) in 20 Obese Healthy Subjects

TypeinterventionalSponsorAphaia Pharma US LLCRan2019 to 2019Enrolled20ConditionsMetabolic Syndrome, ObesityArmscoated beads glucose (8 g) and caffeine anhydrous, coated beads glucose (8 g), uncoated beads glucose (8 g) and caffeine anhydrous
NCT05737927 phase1completednot on this map

Pharmacodynamics and Pharmacokinetics of Different Coated and Uncoated Formulations of Glucose Beads After Single and Multiple Dose Administration Under Fasting Conditions in Obese Healthy Subjects

TypeinterventionalSponsorAphaia Pharma US LLCRan2020 to 2020Enrolled20ConditionsObeseArmsGlucose 8 g coated beads (47% w/w), Glucose 12 g coated beads (47% w/w), Glucose 16 g coated beads (47% w/w), Glucose 12 g uncoated beads, Glucose 12 g coated beads (60% w/w)
NCT05803772 phase2completednot on this map

A Phase II, Randomized, Placebo - Controlled Crossover Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation (APHD-012) in Subjects With a Pathological Oral Glucose Tolerance Test (OGTT)

TypeinterventionalSponsorAphaia Pharma US LLCRan2023 to 2024Enrolled31ConditionsPreDiabetes, Glucose Tolerance ImpairedArmsAPHD-012, APH-012P
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

10 authors.

Kai DeuschDepartment of Physiology, University of Toronto, Toronto, Canada.
Arthur DeboekGalephar Pharmaceutical Research Inc., Humacao, Puerto Rico, USA.
Christian SinaInstitute of Nutritional Medicine, University of Luebeck, Lübeck, Germany.
Coral Capo-VelezAphaia Pharma US LLC, San Juan, Puerto Rico, USA.
Vivianette AliceaAphaia Pharma US LLC, San Juan, Puerto Rico, USA.
Stephan DullerElementrial e.U, Graz, Austria.
Susanne GrafeAphaia Pharma AG, Zug, Switzerland.
Darcy LidingtonDepartment of Physiology, University of Toronto, Toronto, Canada.
Julia HanchardDepartment of Physiology, University of Toronto, Toronto, Canada.
Steffen-Sebastian BolzDepartment of Physiology, University of Toronto, Toronto, Canada.ORCID https://orcid.org/0000-0002-6558-4751

Funding

Aphaia Pharma AGAphaia Pharma US LLC
6 · The paper itself

Abstract

aimsIncretin agonists are used to treat obesity and metabolic dysfunction. Instead of systemically delivering high levels of hormone receptor agonists that can lead to adverse effects, we tested and optimized oral microbead formulations that activate endogenous enteroendocrine signalling systems via distal nutrient-sensing cells. MATERIALS AND

methodsWe report two randomized Phase 1 studies (NCT05713773 and NCT05737927) measuring acute pharmacokinetic/pharmacodynamic responses following consumption of microbeads that deliver glucose to the distal small intestine: these studies compared coating variations and glucose dosing. The primary endpoint was plasma glucagon-like peptide 1 (GLP-1) levels; we also measured GLP-2, PYY, glicentin, oxyntomodulin, glucose-dependent insulinotropic peptide, C-peptide, and insulin as exploratory endpoints. In a subsequent randomized Phase 2a trial (NCT05803772), prediabetic subjects consumed a lead formulation or placebo once daily for 6 weeks each in a two-period, two-sequence crossover design. Oral glucose tolerance was measured at baseline and following treatment in each sequence, with the primary endpoint being the change in the area under the curve.

resultsOur microbead formulation successfully targeted the distal small intestine and elicited a robust plurihormonal enteroendocrine response; our Phase 2a data show that the lead formulation improved glucose tolerance in pre-diabetic patients, comparable to results using GLP-1 mimetics. Adverse events were infrequent and modest.

conclusionsTargeted glucose release activates endogenous enteroendocrine signalling networks, improves a clinically relevant metabolic endpoint, and has minimal adverse effects. The approach to target native enteroendocrine signalling has disruptive potential for the treatment of metabolic disorders, including obesity.

Indexed as

Gastrointestinal HormonesGlucosePrediabetic StateAdultAgedBlood GlucoseCross-Over StudiesEnteroendocrine CellsFemaleGlucagon-Like Peptide 1Glucose Tolerance TestHumansIncretinsMaleMicrospheresMiddle AgedBlood GlucoseGastrointestinal HormonesGlucagon-Like Peptide 1GlucoseIncretinsendocrine therapyGLP‐1incretin physiologyobesity therapypharmacodynamicsweight management

Identifiers

PMID40959944
PMCPMC12587243

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.