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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Eli Lilly's retatrutide MASLD Phase 3 trial (NCT06859268) is enrolling, building on Phase 2 data that reported up to 86% liver-fat reduction at 48 weeks with 93% of 12 mg patients reaching normal liver fat. The MASLD trial will measure histological resolution of steatohepatitis without worsening fibrosis — the endpoint that drives FDA approval in the indication. The trial sits within the broader TRIUMPH program of seven Phase 3 retatrutide readouts due in 2026, after TRIUMPH-4 (28.7% mean weight loss with knee-osteoarthritis pain reduction) and TRANSCEND T2D1 (A1c down 1.7–2.0 pts in T2D). MASLD remains a regulatory test for incretins after Boehringer's survodutide LIVERAGE Phase 3 program.
AstraZeneca's ASCEND program is active in Phase 2b, combining AZD9550 (GLP-1 + glucagon dual agonist) with AZD6234 (selective amylin analog) in a two-molecule triple-mechanism strategy aimed at fat-selective weight loss and organ protection. Individual assets are also in Phase 2. The combination reflects the February 2026 $1.2 billion CSPC Pharmaceuticals collaboration that brought both molecules into AstraZeneca's portfolio, alongside elecoglipron (AZD5004 / ECC5004), the small-molecule oral GLP-1 that posted 5.8% weight loss over four weeks in Phase 1b in China. AstraZeneca enters the next-gen obesity race later than Lilly, Novo, Roche, and Boehringer, but the triple-mechanism positioning targets the safety + organ-protection lane that competitors leave open.
BriaCell announced April 21 preclinical results from its next-generation Bria-OTS+ personalized peptide immunotherapy at the AACR 2026 Annual Meeting. The platform pairs HLA-matched whole-cell allogeneic immunotherapy with peptide-mediated antigen targeting, building on the Bria-IMT clinical foundation in heavily pretreated metastatic breast cancer. Based on the preclinical anti-cancer activity, BriaCell plans to enter the clinic for metastatic breast cancer and prostate cancer indications later in 2026, with lung cancer and melanoma planned for 2027. The program adds to a peptide-immuno-oncology pipeline that includes the Bria-IMT Phase 3 and the company's six accepted ASCO 2026 presentations covering survival data, biomarkers, and quality-of-life endpoints.
BioVaxys presented additional validation data on May 1 supporting its MVP-S DPX-formulated five-peptide survivin vaccine in combination with checkpoint inhibitor pembrolizumab and low-dose cyclophosphamide in recurrent epithelial ovarian cancer. The new data extends the immune-response readout from the PESCO Phase 1B/2 program and reinforces the clinical case heading into the company's accepted ASCO 2026 abstract presentation (May 29–June 6, Chicago). MVP-S sits alongside Bicycle Therapeutics' Duravelo-2, BriaCell's Bria-IMT, Greenwich's GP2, Immutep's eftilagimod alfa, and Pfizer's 40+ oncology abstracts on the ASCO 2026 peptide-and-immuno-oncology slate.
Biomea Fusion announced April 27 positive 52-week Phase 2 COVALENT-112 results in newly diagnosed type 1 diabetes. Patients diagnosed within 0–3 years dosed with icovamenib 200 mg once daily for 12 weeks showed a 52% increase in mean C-peptide AUC at Week 12 (p<0.001, n=5), with persistence through Week 52 (only ~7% decline from baseline) following just 12 weeks of dosing. C-peptide preservation was also observed in patients diagnosed 3–15 years prior (n=9). Icovamenib, a covalent menin inhibitor, was generally well tolerated with no new safety signals. Biomea is planning a Phase 2 expansion at four US academic centers in H2 2026 evaluating extended dosing (6 or 12 months) at 200 mg, with potential addition of an immunosuppressive agent. The data shifts attention back to beta-cell preservation as a T1D therapeutic strategy.
Immutep announced April 22 that an abstract for its lead asset eftilagimod alfa — a soluble LAG-3 protein that activates antigen-presenting cells via MHC class II — has been accepted for poster presentation at ASCO 2026 (May 29–June 2, Chicago). The abstract, titled 'Impact of eftilagimod alfa, an APC activator via MHC class II, on lymphocyte activation and survival outcomes in metastatic cancer patients,' adds a non-checkpoint immunotherapy modality to the ASCO 2026 peptide-and-immuno slate alongside Bicycle Therapeutics' Duravelo-2, BriaCell's Bria-IMT, BioVaxys's MVP-S, and Greenwich LifeSciences' GP2 program.