---
title: "Oral zenagamtide (GLP‑1 and amylin agonist) improves HbA1c in type 2 diabetes: phase 2 dose‑findin"
id: "pubmed-42532079"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42532079"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42532079/"
doi: "10.1016/S0140-6736(26)01247-X"
published_at: "2026-08-15T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Oral zenagamtide (GLP‑1 and amylin agonist) improves HbA1c in type 2 diabetes: phase 2 dose‑findin
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42532079
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42532079/)
- **DOI:** [10.1016/S0140-6736(26)01247-X](https://doi.org/10.1016%2FS0140-6736(26)01247-X)
- **Published At:** 2026-08-15T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This multicentre, randomised, parallel, double‑blind, placebo‑controlled phase 2 trial evaluated once‑daily oral **zenagamtide**, a unimolecular peptide agonist of **GLP‑1** and **amylin** (and calcitonin) receptors, in adults with type 2 diabetes over 36 weeks. - The study enrolled adults aged 18–75 years with HbA1c 7.0–10.0% on stable metformin with or without an SGLT2 inhibitor and BMI 23.0 to <50.0 kg/m2; randomisation was 5:1 (zenagamtide:placebo) and participants were assigned to one of three maintenance doses (6, 25, 50 mg) after stepwise escalation. - The primary efficacy endpoint was change in **HbA1c** from baseline to week 36 assessed using an on‑treatment efficacy estimand without rescue medication; safety was assessed in all treated participants. - 186 participants were randomised and included in the full analysis set: 54 to 6 mg, 51 to 25 mg, 51 to 50 mg, and 30 to placebo. - At week 36, estimated mean HbA1c changes from baseline were −0.9% (6 mg), −1.3% (25 mg), and −1.4% (50 mg). All three doses showed statistically significant reductions versus placebo with reported estimated treatment differences (ETD) and p values. - The ETDs versus placebo were −0.5% (6 mg; 95% CI −1.04 to −0.04; p=0.033), −0.99% (25 mg; 95% CI −1.49 to −0.49; p=0.0001), and −1.09% (50 mg; 95% CI −1.59 to −0.59; p<0.0001). - The most common adverse events were gastrointestinal; incidence increased with dose (26% at 6 mg, 41% at 25 mg, 47% at 50 mg) versus 23% with placebo. - Serious adverse events were reported in seven treated participants receiving zenagamtide (two in 6 mg, two in 25 mg, three in 50 mg); there were no deaths and no serious adverse events in the placebo group. - Investigators concluded that once‑daily oral **zenagamtide** produced clinically meaningful and significant HbA1c improvements at all tested doses and had a safety/tolerability profile consistent with other **GLP‑1 and amylin receptor agonists**. Funding was provided by Novo Nordisk. - Trial registration: ClinicalTrials.gov NCT06542874. The full trial methods, secondary outcomes, and longer‑term data were not detailed in the abstract.
## Clinical Analysis & Structured Key Points
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Epub 2026 Jul 30. # Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial [Pablo Mora](https://pubmed.ncbi.nlm.nih.gov/?term=Mora+P&cauthor_id=42532079)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-1 "University of Texas, Southwestern Medical Center, Dallas, TX, USA; Tekton Research, McKinney, TX, USA. Electronic address: pablo.mora@tektonresearch.com."), [Vanita R Aroda](https://pubmed.ncbi.nlm.nih.gov/?term=Aroda+VR&cauthor_id=42532079)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-2 "Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA."), [Marisse Asong](https://pubmed.ncbi.nlm.nih.gov/?term=Asong+M&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Matthias Blüher](https://pubmed.ncbi.nlm.nih.gov/?term=Bl%C3%BCher+M&cauthor_id=42532079)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-4 "Helmholtz Institute for Metabolic, Obesity and Vascular Research, Helmholtz Center Munich, Leipzig University and University of Leipzig Medical Center, Leipzig, Germany; University of Leipzig Medical Center, Leipzig, Germany."), [Amanda-Louise Fenger Carlander](https://pubmed.ncbi.nlm.nih.gov/?term=Carlander+AF&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Morten Kaltoft](https://pubmed.ncbi.nlm.nih.gov/?term=Kaltoft+M&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Louise Nygaard Vilsen](https://pubmed.ncbi.nlm.nih.gov/?term=Vilsen+LN&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Julio Rosenstock](https://pubmed.ncbi.nlm.nih.gov/?term=Rosenstock+J&cauthor_id=42532079)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#full-view-affiliation-5 "University of Texas, Southwestern Medical Center, Dallas, TX, USA.") Affiliations Expand ### Affiliations * 1 University of Texas, Southwestern Medical Center, Dallas, TX, USA; Tekton Research, McKinney, TX, USA. Electronic address: pablo.mora@tektonresearch.com. * 2 Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. * 3 Novo Nordisk, Søborg, Denmark. * 4 Helmholtz Institute for Metabolic, Obesity and Vascular Research, Helmholtz Center Munich, Leipzig University and University of Leipzig Medical Center, Leipzig, Germany; University of Leipzig Medical Center, Leipzig, Germany. * 5 University of Texas, Southwestern Medical Center, Dallas, TX, USA. * PMID: **42532079** * DOI: [ 10.1016/S0140-6736(26)01247-X ](https://doi.org/10.1016/s0140-6736\(26\)01247-x) Item in Clipboard Clinical Trial # Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial Pablo Mora et al. Lancet. 2026. Show details Display options Display options Format Abstract PubMed PMID Lancet Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Lancet%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Lancet%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42532079/) . 2026 Aug 15;408(10555):607-620. doi: 10.1016/S0140-6736(26)01247-X. Epub 2026 Jul 30. ### Authors [Pablo Mora](https://pubmed.ncbi.nlm.nih.gov/?term=Mora+P&cauthor_id=42532079)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-1 "University of Texas, Southwestern Medical Center, Dallas, TX, USA; Tekton Research, McKinney, TX, USA. Electronic address: pablo.mora@tektonresearch.com."), [Vanita R Aroda](https://pubmed.ncbi.nlm.nih.gov/?term=Aroda+VR&cauthor_id=42532079)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-2 "Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA."), [Marisse Asong](https://pubmed.ncbi.nlm.nih.gov/?term=Asong+M&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Matthias Blüher](https://pubmed.ncbi.nlm.nih.gov/?term=Bl%C3%BCher+M&cauthor_id=42532079)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-4 "Helmholtz Institute for Metabolic, Obesity and Vascular Research, Helmholtz Center Munich, Leipzig University and University of Leipzig Medical Center, Leipzig, Germany; University of Leipzig Medical Center, Leipzig, Germany."), [Amanda-Louise Fenger Carlander](https://pubmed.ncbi.nlm.nih.gov/?term=Carlander+AF&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Morten Kaltoft](https://pubmed.ncbi.nlm.nih.gov/?term=Kaltoft+M&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Louise Nygaard Vilsen](https://pubmed.ncbi.nlm.nih.gov/?term=Vilsen+LN&cauthor_id=42532079)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-3 "Novo Nordisk, Søborg, Denmark."), [Julio Rosenstock](https://pubmed.ncbi.nlm.nih.gov/?term=Rosenstock+J&cauthor_id=42532079)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42532079/#short-view-affiliation-5 "University of Texas, Southwestern Medical Center, Dallas, TX, USA.") ### Affiliations * 1 University of Texas, Southwestern Medical Center, Dallas, TX, USA; Tekton Research, McKinney, TX, USA. Electronic address: pablo.mora@tektonresearch.com. * 2 Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. * 3 Novo Nordisk, Søborg, Denmark. * 4 Helmholtz Institute for Metabolic, Obesity and Vascular Research, Helmholtz Center Munich, Leipzig University and University of Leipzig Medical Center, Leipzig, Germany; University of Leipzig Medical Center, Leipzig, Germany. * 5 University of Texas, Southwestern Medical Center, Dallas, TX, USA. * PMID: **42532079** * DOI: [ 10.1016/S0140-6736(26)01247-X ](https://doi.org/10.1016/s0140-6736\(26\)01247-x) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Zenagamtide (formerly amycretin) is a unimolecular peptide agonist of GLP-1, amylin, and calcitonin receptors. We aimed to investigate the dose-response relationship with respect to the efficacy and safety of once-daily oral zenagamtide compared with placebo in adults with type 2 diabetes. **Methods:** This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries. The trial consisted of a 3-week screening period, a 36-week intervention period, and a 4-week follow-up period. Adults (aged 18-75 years) with type 2 diabetes (glycated haemoglobin [HbA1c] 7·0-10·0% [53-86 mmol/mol]), treated with stable doses of metformin with or without a SGLT2 inhibitor, and with a BMI of 23·0 to <50·0 kg/m2 were randomly assigned (5:1) to oral zenagamtide or placebo using a randomisation and trial supplies management system, then further randomly assigned (1:1:1) to one of three dose groups (6, 25, or 50 mg). Participants assigned to placebo were similarly assigned to matched placebo regimens corresponding to each dosing schedule. Randomisation was stratified by HbA1c (<8·5% or ≥8·5%) at screening and country of residence (Japan or other countries). The starting dose of oral zenagamtide was 1·5 mg, with dose escalations every 4 weeks until the maintenance dose was reached (6, 25, or 50 mg). Participants and staff were masked within each dose level to placebo or zenagamtide. The primary outcome was change in HbA1c from baseline to week 36. The primary outcome was assessed in all randomly assigned participants using the efficacy estimand based on on-treatment data without rescue medication. Safety outcomes were assessed in all randomly assigned participants exposed to treatment. This trial is registered with ClinicalTrials.gov, [NCT06542874](http://clinicaltrials.gov/show/NCT06542874 "See in ClinicalTrials.gov"), and is completed. **Findings:** Between Aug 7 and Dec 27, 2024, 186 (20%) of 915 screened participants were randomly assigned to oral zenagamtide (54 participants to 6 mg, 51 participants to 25 mg, and 51 participants to 50 mg) or placebo (30 participants) and were included in the full analysis set. At week 36, from baseline (mean range 7·9-8·1%), estimated mean change in HbA1c was -0·9% with zenagamtide 6 mg (estimated treatment difference [ETD] vs placebo -0·5% [95% CI -1·04 to -0·04]; p=0·033), -1·3% with zenagamtide 25 mg (-0·99% [-1·49 to -0·49]; p=0·0001), and -1·4% with zenagamtide 50 mg (-1·09% [-1·59 to -0·59]; p<0·0001). The most common adverse events were gastrointestinal, occurring in 14 (26%) of 54 participants in the zenagamtide 6 mg group, 21 (41%) of 51 participants in the zenagamtide 25 mg group, 24 (47%) of 51 participants in the zenagamtide 50 mg group, and seven (23%) of 30 participants in the placebo group. Serious adverse events were reported in seven (4%) of 186 participants receiving zenagamtide: two in the 6 mg group, two in the 25 mg group, and three in 50 mg group. No serious adverse events were reported in the placebo group. No deaths occurred during the trial. **Interpretation:** In people with type 2 diabetes, once-daily oral zenagamtide showed clinically meaningful and significant improvements in HbA1c from baseline to week 36 compared with placebo at all three dose levels (6, 25, and 50 mg). The safety and tolerability of oral zenagamtide was consistent with other GLP-1 and amylin receptor agonists. **Funding:** Novo Nordisk. Copyright © 2026 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of interests PM has received honoraria as a consultant for Abbott, Biomea Fusion, Dexcom, Insulet, Minimed (Medtronic), and Novo Nordisk, and is a member of the speakers’ bureau for Abbott, Dexcom, Insulet, Minimed (Medtronic), and Novo Nordisk. VRA reports institutional contracts with Amgen, Applied Therapeutics, AstraZeneca, Biomea Fusion, Corcept Therapeutics, Eli Lilly, Fractyl Health, Kailera Therapeutics, Novo Nordisk, Pfizer, Recordati, Rhythm Pharmaceuticals, and Servier, and has received consultancy fees from the Baim Institute for Clinical Research, Mediflix, Roche, and Sanofi. MB has received honoraria as a consultant and speaker from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi–Sankyo, Lilly, MSD, Novo Nordisk, Novartis, Pfizer, and Sanofi, and reports chairing a clinical trial data safety monitoring board for Boehringer Ingelheim. MA, A-LFC, MK, and LNV are employees and shareholders of Novo Nordisk. JR reports clinical research grants from Amgen, Applied Therapeutics, AstraZeneca, Biomea Fusion, Boehringer Ingelheim, Corcept Therapeutics, Corxel, Eli Lilly, Hanmi Pharmaceutical, Merck, Novo Nordisk, Pfizer, Regeneron, Roche, Regor Therapeutics, Sanofi, Structure Therapeutics, and Terns Pharma; serves or has served on scientific advisory boards for, and has received honoraria or consulting fees from, Amgen, Applied Therapeutics, Arrowhead Pharmaceuticals, Biomea Fusion, Boehringer Ingelheim, Corcept, Eccogene, Eli Lilly, Hanmi Pharmaceutical, i2O Therapeutics, Novo Nordisk, Regeneron, Roche, Sanofi, Structure Therapeutics, and Terns Pharma; and has received honoraria for lectures from Eli Lilly, Novo Nordisk, and Sanofi. ## Similar articles * [ Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. ](https://pubmed.ncbi.nlm.nih.gov/31186120/) Pratley R, Amod A, Hoff ST, Kadowaki T, Lingvay I, Nauck M, Pedersen KB, Saugstrup T, Meier JJ; PIONEER 4 investigators.Pratley R, et al.Lancet. 2019 Jul 6;394(10192):39-50. doi: 10.1016/S0140-6736(19)31271-1. Epub 2019 Jun 8.Lancet. 2019.PMID: 31186120Clinical Trial. * [ Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial. ](https://pubmed.ncbi.nlm.nih.gov/42259343/) Aroda VR, Davies MJ, Maaske J, Millegård M, Juan VL, Aberle J, Ciudin A, McCrimmon RJ, Eklund O, Shih JL, Sjostrand M, Zarzuela D, Rosenstock J.Aroda VR, et al.Lancet. 2026 Jun 20;407(10547):2515-2527. doi: 10.1016/S0140-6736(26)00802-0. Epub 2026 Jun 8.Lancet. 2026.PMID: 42259343Clinical Trial. * [ Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. ](https://pubmed.ncbi.nlm.nih.gov/37385280/) Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T.Rosenstock J, et al.Lancet. 2023 Aug 12;402(10401):529-544. doi: 10.1016/S0140-6736(23)01053-X. Epub 2023 Jun 26.Lancet. 2023.PMID: 37385280Clinical Trial. * [ Safety, tolerability, pharmacokinetics, and pharmacodyn
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