Peptide News Digest

Clinical Trials News

145 stories across all digests

Clinical trial coverage on Peptide News Digest pulls in Phase 1 through Phase 3 readouts across the peptide universe — GLP-1 obesity and cardiometabolic trials (SELECT, SURMOUNT-4, ACHIEVE-3, REDEFINE-1, SYNCHRONIZE-1), peptide vaccine work (AMPLIFY-201, MEL39), peptide-drug conjugate trials, and antimicrobial peptide programs.

Most of the noise sits with Lilly and Novo, but the interesting reads are usually elsewhere: Bicycle Therapeutics on solid tumors, Lirum on Ewing sarcoma, Cerapedics on lumbar fusion, Pelage on hair loss. Real-world evidence and registry data also land here when they reframe what the randomized trials showed.

Each entry names the sponsor, the phase, and the endpoint. Browse the latest below, or jump to the readouts by drug at #semaglutide, #tirzepatide, or #orforglipron.

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Entera Bio Q1 2026: EB613 Oral PTH(1-34) Tablet Phase 3 Plan Submitted to FDA, 750-Patient Postmenopausal Osteoporosis Trial Slated for Late 2026, Topline H2 2028

Entera Bio reported Q1 2026 May 8 with $20.4M cash and an updated Phase 3 plan for EB613, an oral once-daily PTH(1-34) tablet that would be the first oral osteoanabolic for postmenopausal osteoporosis. The streamlined Phase 3 protocol — submitted to the FDA in March — covers 750 postmenopausal women with primary endpoint of total hip BMD change from baseline at month 12. Trial initiation is targeted for late 2026, with topline H2 2028 — roughly one year earlier than previously guided. The molecule applies Entera's N-Tab oral peptide platform to teriparatide, the active ingredient in Forteo. The Phase 2 dose-ranging study in 161 patients met primary (PD/bone-turnover biomarker) and secondary (BMD) endpoints.

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MBX Biosciences Obesity Portfolio Update: MBX 4291 Phase 1 Once-Monthly Profile, MBX 5765 Amycretin Prodrug Nominated, Imapextide Phase 2a STEADI Hits Proof of Concept in Post-Bariatric Hypoglycemia

MBX Biosciences (Nasdaq: MBX) released a May 11 obesity portfolio update covering three programs. MBX 4291, a GLP-1/GIP co-agonist prodrug, posted preliminary blinded Phase 1 MAD Part B data showing a T1/2Cmax1 of ~26 days, consistent with true once-monthly dosing; 12-week MAD Part C data expected Q4 2026. MBX 5765, a new amycretin prodrug combining GLP-1, GIP, glucagon, and DACRA (dual amylin and calcitonin receptor agonist) activity in a single construct, is in IND-enabling studies starting Q2 2026. Once-weekly imapextide hit proof of concept in the Phase 2a STEADI trial in post-bariatric hypoglycemia, with glucose nadir increased 17-34% across doses and insulin peak decreased 11-45% — directly competing with Amylyx's avexitide (Phase 3 LUCIDITY topline Q3 2026) for the same indication.

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Viking Therapeutics ECO 2026 Posters: VK2735 Phase 2 VENTURE-Oral 13-Week Efficacy + Phase 3 VANQUISH-1 Subcutaneous Design

Viking Therapeutics announced two poster presentations at ECO 2026 in Istanbul (May 12-15) on its VK2735 dual GLP-1/GIP agonist program. The first poster details 13-week efficacy and safety data from the Phase 2 VENTURE-Oral trial of oral VK2735, supporting Viking's Q4 2026 plan to launch a Phase 3 trial of the oral formulation following positive FDA feedback. The second poster details Phase 3 VANQUISH-1 design and enrollment demographics for subcutaneous VK2735, which completed enrollment of approximately 4,650 adults with obesity in November 2025. VANQUISH-2 (subcutaneous VK2735 in T2D + obesity, ~1,000 adults) completed enrollment March 26, 2026. Posters display May 12-15 with networking sessions Thursday May 14 18:00-19:15 TRT.

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Ascletis Multi-Program ECO 2026 Slate: ASC47 + Semaglutide 111.8% Greater Relative Weight Loss, ASC36 Once-Monthly Amylin 32-Day Half-Life, ASC35 Dual GLP-1R/GIPR 14-Day Half-Life

Ascletis Pharma will present multiple poster sessions at ECO 2026 covering programs beyond the already-presented ASC30. ASC47, an adipose-targeting thyroid hormone receptor beta (THRβ) agonist designed for muscle-preserving weight loss, demonstrated up to 111.8% greater relative weight loss when combined with semaglutide vs semaglutide monotherapy in obesity participants. ASC36, a once-monthly next-generation amylin receptor agonist peptide, posted a 32-day average observed half-life — six times longer than Zealand's petrelintide. ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist peptide, showed a 14-day average observed half-life (six times longer than tirzepatide) and 71% more relative weight loss than tirzepatide in a diet-induced obesity mouse model. Session Thursday May 14, 18:00-19:15 TRT.

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Padova-Led STEP Pooled 65+ Analysis at ECO 2026: Semaglutide 2.4 mg Delivered 15.4% Weight Loss vs 5.1% Placebo, 28.6% of Older Adults Hit ≥20%

Prof. Luca Busetto (University of Padova) and colleagues will present at ECO 2026 a pooled subgroup analysis of 358 adults aged 65 and older (mean age 69, 72% women) drawn from STEP 1, 3, 4, 5, 8, and 9 — 248 received semaglutide 2.4 mg, 110 placebo. The semaglutide arm lost 15.4% body weight on average vs 5.1% on placebo; 46.8% of semaglutide users hit ≥15% weight loss vs 6.4% on placebo, and 28.6% reached ≥20% vs 2.7%. Waist circumference fell 14.3 cm vs 6.0 cm. 27% on semaglutide reached a healthy BMI (<27) vs 5.5%. Serious adverse events occurred in 19.0% on semaglutide vs 12.7% on placebo. The analysis complements Lilly's ECO 2026 orforglipron 65+ subgroup analysis from ATTAIN-1 and ATTAIN-2 — both filling the geriatric data gap for the first generation of mainstream obesity drugs.

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Avacta AVA6000 FAP-Dox Peptide-Drug Conjugate Set for ASCO 2026 Oral Presentation in FAP-Positive Salivary Gland and Solid Tumors

Avacta Therapeutics's AVA6000, a fibroblast activation protein (FAP)-activated peptide-drug conjugate releasing doxorubicin selectively in the tumor microenvironment, will be presented at ASCO 2026 (Chicago, May 29-June 2) covering Phase Ia/Ib data in FAP-positive solid tumors with activity against salivary gland cancers — a rare cancer subset with no approved targeted therapies. The pre|CISION platform attaches a peptide tetrazolyl moiety that is cleaved by FAP, an enzyme overexpressed in cancer-associated fibroblasts and selectively present in the tumor stroma, allowing systemic dosing without the cardiotoxicity that limits free doxorubicin. AVA6000 joins Bicycle's nuzefatide pevedotin and Lilly's CRN09682 in the broader peptide-drug conjugate Phase 2/3 cohort.

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Amylyx Launches U.S. Expanded Access Program for Avexitide — First-in-Class Peptide GLP-1 Receptor Antagonist in Post-Bariatric Hypoglycemia

Amylyx Pharmaceuticals on May 5 launched a U.S. Expanded Access Program (EAP) for up to 250 adults with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery. The investigational compound, avexitide, is a first-in-class peptide GLP-1 *receptor antagonist* — designed to bind GLP-1 receptors on pancreatic islet beta cells and block the exaggerated GLP-1-driven insulin response characteristic of PBH, reducing inappropriate insulin secretion and stabilizing blood glucose. Avexitide carries FDA Breakthrough Therapy Designation for both PBH and congenital hyperinsulinism, plus Orphan Drug Designation. Topline data from the pivotal Phase 3 LUCIDITY trial are anticipated in Q3 2026. The program inverts the standard GLP-1 narrative — for this population, GLP-1 signaling is the problem.

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Ascletis ASC30 Posters at ECO 2026: Once-Monthly Subcutaneous Depot Shows 7.5% Placebo-Adjusted Weight Loss at 16 Weeks

Ascletis announced multiple poster presentations at the 33rd European Congress on Obesity (ECO 2026) opening May 12 in Istanbul. ASC30, a first-in-class small-molecule GLP-1R fully biased agonist developed for once-daily oral and once-monthly to once-quarterly subcutaneous dosing, will be featured across formulation, PK, and clinical-data posters. The Phase 2 13-week study previously reported 7.7% placebo-adjusted weight loss at 60 mg oral dosing; the once-monthly subQ depot formulation achieved 7.5% placebo-adjusted weight loss at 16 weeks after three monthly doses, with topline T2D Phase 2 data expected Q3 2026. The subQ depot angle directly challenges Pfizer's MET-097i monthly thesis with a different mechanism (small-molecule GLP-1R biased agonist vs ultra-long-acting peptide).

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Lilly ECO 2026 Preview: Orforglipron Post-Hoc Subgroup Analysis in Adults Aged 65+ Drawn from ATTAIN-1 + ATTAIN-2 Phase 3 Pool

A post-hoc subgroup analysis of Eli Lilly's orforglipron (Foundayo) in adults aged 65 and older, drawn from the ATTAIN-1 and ATTAIN-2 Phase 3 programs, will be presented at ECO 2026 in Istanbul May 12-15. The analysis pools 616 randomized participants (613 treated) — 118 on 6 mg, 135 on 12 mg, 146 on 36 mg orforglipron, and 214 placebo — across patients with and without type 2 diabetes. The geriatric data set addresses a long-standing clinical gap: incretin trials have systematically underenrolled adults over 65, the population most affected by obesity-related comorbidities and the most likely to face polypharmacy-related GI tolerability concerns. Lead author Dr. Deborah Horn (UTHealth Houston McGovern Medical School). The presentation is among the ECO 2026 abstracts that will shape geriatric prescribing patterns for the first FDA-approved GLP-1 pill that does not require fasting or water restrictions.

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Rhythm Q1 2026: IMCIVREE Net Revenue $60.1M (+59% YoY) on Hypothalamic Obesity Launch — EMANATE Phase 3 Misses in All Four MC4R Substudies

Rhythm Pharmaceuticals reported Q1 2026 results May 5: setmelanotide (IMCIVREE) net product revenue of $60.1M, up from $37.7M a year earlier ($36.9M US, $23.2M ex-US), driven by 150+ new US start forms in acquired hypothalamic obesity following the FDA approval and the EU Marketing Authorization for the same indication; Japan's PMDA accepted the NDA for review. The MC4R-agonist peptide is the only commercial therapy for hypothalamic obesity. Offsetting the topline beat: the Phase 3 EMANATE trial in genetically caused MC4R-pathway diseases failed its primary endpoint in all four independent substudies, narrowing the indication-expansion runway. Net loss was $56.7M; cash $340.6M for 24+ months runway.

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Vertex Q1: VX-670 Cyclic-Peptide-Oligonucleotide DM1 Conjugate On Track for GALILEO Phase 1/2 Readout in H2 2026

Vertex Pharmaceuticals' Q1 business update confirmed continued enrollment and dosing in the multiple-ascending-dose portion of GALILEO, the global Phase 1/2 study of VX-670 in adults with myotonic dystrophy type 1, with results guided for H2 2026. VX-670 is an oligonucleotide linked to a cyclic peptide endosomal-escape vehicle from Entrada Therapeutics' EEV platform; the oligonucleotide engages CUG-repeat RNA to liberate bound MBNL1 splicing factor and correct the upstream missplicing that drives DM1 pathology. The trial is the first clinical readout for the Vertex–Entrada DM1 collaboration, originally signed February 2023 with $250M upfront. DM1 has no disease-modifying therapy.

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Frontiers in Endocrinology: Multicenter Real-World Cohort Maps Semaglutide Use in Type-2 Diabetes Plus End-Stage Renal Disease

A Frontiers in Endocrinology multicenter retrospective cohort study (2026) reports real-world safety and effectiveness of semaglutide in patients with type 2 diabetes and end-stage renal disease — the population systematically excluded from FLOW (which capped at eGFR ≥ 25) and the SELECT pre-specified kidney composite analysis. ESRD patients comprise roughly 1% of the diabetic population but 7% of US healthcare spending; their cardiovascular event rates are among the highest documented. The cohort fills a clinical gap: prescribers managing dialysis-dependent patients have had to extrapolate from outcome trials that explicitly excluded the population. Work joins the SOUL oral-semaglutide CKD analysis as the fastest-growing GLP-1 evidence stream beyond obesity and T2D.

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AstraZeneca Eleglipron Phase 2b VISTA + SOLSTICE Met Primary Endpoints; Comprehensive Phase 3 Obesity Program Confirmed at Q1 Print, Full Data Slot at ADA 2026 in June

AstraZeneca's eleglipron (formerly elecoglipron / AZD5004 / ECC5004), the oral small-molecule GLP-1 agonist licensed from Eccogene in 2023, met primary endpoints in two Phase 2b trials with results detailed at the company's April 29 Q1 print: VISTA (NCT06579092, 310 obesity patients, 26-week weight loss) and SOLSTICE (NCT06579105, 406 type-2 diabetes patients, 26-week HbA1c change vs semaglutide and placebo). AstraZeneca held back exact weight-loss numbers, framing the molecule as 'very competitive,' with full data scheduled for the American Diabetes Association meeting in June. The company committed to a comprehensive Phase 3 program targeting both weight-loss efficacy and outcome benefits, with monotherapy and fixed-dose combination programs anchored against the SYH2082 dual-agonist and LiquidGel monthly-dosing platform from the $18.5B CSPC Pharmaceuticals collaboration.

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Entrada Therapeutics ENTR-601-44 Phase 1/2 ELEVATE-44-201 Topline (May 7): 2.36% Mean Dystrophin Increase, Statistically Significant Time-to-Rise Velocity, Clean Safety at 6 mg/kg in Duchenne Muscular Dystrophy

Entrada Therapeutics announced May 7 positive topline results from Cohort 1 of the Phase 1/2 ELEVATE-44-201 study of ENTR-601-44, the first-in-class Endosomal Escape Vehicle (EEV) peptide-PMO conjugate for exon-44-amenable Duchenne muscular dystrophy. At 6 mg/kg, treated participants showed mean dystrophin increase of 2.36% from a 4.00% baseline, exon-skipping increase of 2.31% from a 2.66% baseline, and a statistically significant improvement in Time-to-Rise (TTR) velocity. No serious adverse events or treatment-driven discontinuations; the most common AE was headache. All eight Cohort 1 participants transitioned to the open-label portion. Cohort 2 (12 mg/kg) is now dosing, with year-end 2026 readouts planned for Cohort 1 OLE and Cohort 2 MAD; Cohort 3 (up to 18 mg/kg) follows.

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Bicycle Therapeutics Duravelo-2 Oral Abstract Confirmed for ASCO 2026 June 1 (8:30 a.m. CT): Zelenectide Pevedotin (BT8009) + Pembrolizumab Interim Analysis in 1L Locally Advanced/Metastatic Urothelial Cancer

Bicycle Therapeutics confirmed the Duravelo-2 oral abstract presentation slot at the ASCO 2026 Annual Meeting on Monday, June 1, 8:30–8:36 a.m. CT. The abstract reports interim analysis results from Duravelo-2, a Phase 2/3 trial of zelenectide pevedotin (BT8009) plus pembrolizumab as first-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma. Zelenectide pevedotin is Bicycle's Nectin-4-targeting bicyclic peptide-drug conjugate, a separate program from the EphA2-targeting nuzefatide pevedotin (BT5528) covered earlier on this site. The Q1 2026 print (April 30) reaffirmed $559.5M cash and runway to 2030 supporting the Phase 3 expansion of the platform.

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Eli Lilly + Indiana Biosciences Quintuple Agonist (GLP-1/GIP/Glucagon/Amylin/Calcitonin) Animal Data Set for ADA 2026 May 29 Plenary

Eli Lilly, with the Indiana Biosciences Research Institute, has disclosed an ADA Scientific Sessions Late-Breaking Poster slot (Poster 2839-LB, May 29) for a single peptide molecule that simultaneously activates five receptors: GLP-1, GIP, glucagon, amylin, and calcitonin. Lead investigator Jonathan Douros, PhD, will present rodent data showing weight-loss superiority over retatrutide in Lilly-sponsored animal studies. The compound is distinct from the DiMarchi/Tschöp/Müller GLP-1R/GIPR/PPARα/γ/δ quintuple agonist published in Nature on April 30 — that one is a peptide-drug conjugate combining GLP-1/GIP with the pan-PPAR agonist lanifibranor, while the Lilly + Indiana Biosciences molecule appears to be a single peptide hitting all five receptors directly. Both signal that the obesity-pharmacology ceiling is moving past the triple-agonist generation.

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Wegovy HD 7.2 mg Q1 Contribution: STEP UP Trial 21% Mean Weight Loss at 72 Weeks Anchors Premium-Tier Adoption

Novo Nordisk's Q1 print clarified that Wegovy HD (semaglutide 7.2 mg injection) — approved by the FDA in March and launched in the US on April 7 — is contributing to the premium-tier injectable mix alongside the standard 2.4 mg dose. The STEP UP trial showed 21% mean weight loss at 72 weeks if all patients stayed on treatment (19% regardless), with 89% on 7.2 mg achieving ≥5% body-weight reduction versus 38% with placebo. The label requires four-plus weeks of tolerability on semaglutide 2.4 mg before stepping up. NovoCare prices the 7.2 mg dose at $399/month self-pay and as low as $25 for many commercially insured patients via the savings offer. Dysesthesia at 22% on 7.2 mg vs. 6% on 2.4 mg and 0.3% on placebo is the only meaningful safety signal beyond the broader GLP-1 class.

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Novo CagriSema Higher-Dose Phase 3 Trial Set for H2 2026 After February Failure to Match Zepbound; FDA Filing Already Submitted with Late-2026 Decision Window

Novo Nordisk confirmed in its Q1 2026 commentary that a higher-dose CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) Phase 3 trial will start in the second half of 2026, in response to the February 23 readout where the lower-dose 2.4/2.4 mg arm achieved 23% mean weight loss vs. 25.5% on tirzepatide 15 mg over 84 weeks — failing the non-inferiority primary endpoint. The original CagriSema FDA filing is already submitted with a decision expected in late 2026; the higher-dose program is meant to position Novo for a more competitive head-to-head against tirzepatide before the retatrutide TRIUMPH readouts arrive. ECO 2026 in Istanbul (May 12–15) will deliver additional CagriSema data alongside Wegovy 7.2 mg.