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.
Zealand Pharma announced on Tuesday, September 29, 2026 that the Phase 2 ZUPREME-1 trial of petrelintide, its once-weekly human amylin analog partnered with Roche, has been published in The Lancet Diabetes & Endocrinology, with more results due in an EASD oral presentation on September 30. The trial randomized 485 adults with obesity (mean BMI 36.7) to weekly petrelintide at 1.0 to 9.0 mg or placebo for 42 weeks, including dose escalation. Mean weight loss reached up to 10.7% versus 1.7% with placebo under the efficacy estimand and up to 10.2% versus 1.4% under the treatment-policy estimand; waist circumference fell up to 10.8 cm versus 4.3 cm, and high-sensitivity C-reactive protein fell up to 41% versus 6%. Zealand said gastrointestinal side effects were mostly mild and at rates similar to placebo, with no vomiting and no GI-related discontinuations at the maximally effective dose.
Innsbruck-based Cyprumed announced on Tuesday, September 29, 2026 that MSD (Merck & Co.) has begun a Phase 1 trial of one of its proprietary drug candidates formulated with Cyprumed's oral delivery technology, the first time the technology has been tested in people; the candidate was not disclosed. Cyprumed's tablet formulations are designed to let therapeutic peptides, including GLP-1 analogs, macrocycles, and mini-proteins, be absorbed when swallowed, using approved excipients. The trial start triggers a milestone payment under the companies' April 2025 non-exclusive license and option agreement to develop oral versions of MSD's peptides, under which Cyprumed can receive up to $493 million.
Chugai announced on Monday, September 28, 2026 that Roche is discontinuing development of emugrobart (GYM329), a subcutaneous anti-latent myostatin antibody, for obesity after an interim analysis of the Phase 2 GYMINDA study concluded that the trial was unlikely to meet its pre-specified weight-loss objectives. GYMINDA tested emugrobart in combination with GLP-1/GIP receptor agonists in people with obesity or overweight; Chugai said the antibody was well tolerated, with no new safety signals. All rights return to Chugai, which is preparing to resume development in spinal muscular atrophy and considering out-licensing; Roche had already stopped emugrobart development in spinal muscular atrophy and facioscapulohumeral muscular dystrophy in March 2026.
Roche announced on Tuesday, September 22, 2026 that enicepatide (CT-388), an investigational once-weekly GLP-1/GIP receptor agonist, met both primary endpoints in the randomized, placebo-controlled Phase 2 CT-388-104 trial in 447 adults with type 2 diabetes and overweight or obesity. At the highest titrated dose of 24 mg, HbA1c fell 2.65 percentage points from a baseline of 8.1%, mean weight loss was 15.5% at 48 weeks with no plateau, and 90% of patients on that dose reached an HbA1c of 6.5% or lower. Discontinuation due to adverse events was 2.0% across enicepatide arms versus 0.0% on placebo, and side effects were mostly mild-to-moderate gastrointestinal. Roche's announcement did not give placebo results for weight or HbA1c; the company plans a Phase 3 glycemic-control program and cardiovascular outcomes trials in the first half of 2027, alongside the ongoing ENITH-1 and ENITH-2 weight-management trials.
Avacta Group announced on Friday, September 25, 2026 that it would present the design of its Phase 1a FOCUS-01 trial and new preclinical data for AVA6103 (FAP-Exd) on September 26 at the AACR Conference on Pancreatic Cancer in San Diego. AVA6103 is a peptide-drug conjugate built on Avacta's pre|CISION platform, which is designed to be cleaved inside the tumor by fibroblast activation protein (FAP) so that the chemotherapy payload exatecan is released there, limiting exposure elsewhere in the body. The company said AVA6103 was well tolerated through the first three dose levels, up to a payload dose about 50% above the maximum tolerated dose of conventional exatecan, and that enrollment continues at dose level 4, including an every-two-weeks arm for pancreatic cancer. In mice implanted with human tumor tissue, Avacta reported durable complete and partial responses lasting weeks after dosing stopped; it released no efficacy data from patients.
Zealand Pharma announced on September 22, 2026 the start of the Phase 3a ZUPREME program for petrelintide, its once-weekly subcutaneous amylin analog partnered with Roche. The three placebo-controlled trials are ZUPREME-3 (about 3,900 people with overweight or obesity and at least one weight-related comorbidity, without type 2 diabetes), ZUPREME-4 (about 600 people with type 2 diabetes), and ZUPREME-5 (about 2,500 people with established cardiovascular disease). Each trial's primary endpoint is percentage change in body weight from baseline to week 64. A Phase 2 trial combining petrelintide with Roche's GLP-1/GIP agonist enicepatide (CT-388) is planned for the second half of 2026.
AC Immune reported on September 23, 2026 that Part 1 of VacSYn, a randomized, double-blind, placebo-controlled Phase 2 trial in early Parkinson's disease, met all of its primary safety, tolerability, and immunogenicity endpoints through week 100. Thirty-four patients were randomized 3:1 to ACI-7104 or placebo; the company said 100% of patients developed antibodies against the PD01 antigen after three immunizations, antibodies reached the cerebrospinal fluid in all patients, and the vaccine was generally safe and well tolerated. ACI-7104.056 uses an eight-amino-acid peptide that mimics a C-terminal alpha-synuclein epitope, conjugated to keyhole limpet hemocyanin, according to Alzforum. AC Immune reported a CSF total alpha-synuclein signal consistent with target engagement but no clinical efficacy result, and plans FDA meetings in early 2027 before an expanded Phase 2.
Roche said on September 23, 2026 that a prespecified interim analysis of the Phase 3 IMAgINATION trial found sefaxersen produced a statistically significant reduction in 24-hour urine protein-to-creatinine ratio versus placebo at 37 weeks in adults with primary IgA nephropathy at high risk of progression. The trial randomized 459 people 1:1 to sefaxersen, a once-monthly subcutaneous antisense drug that reduces liver production of complement factor B, or to placebo for 105 weeks. Roche did not disclose the size of the proteinuria reduction; the trial remains blinded to week 105 to measure change in eGFR, and safety was consistent with prior data. Roche licensed sefaxersen from Ionis.
Amgen announced on September 22, 2026 that OASIZ 301, a randomized, double-blind, placebo-controlled Phase 3 trial in about 621 adults with Sjögren's disease and moderate-to-severe systemic activity (ESSDAI of 5 or higher), met its primary endpoint of change from baseline in ESSDAI at week 48. Amgen described the improvement as statistically significant and seen as early as week 4, but did not release effect sizes. The company describes dazodalibep as a potential first-in-class CD40L antagonist fusion protein. The most common adverse events were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions; a second Phase 3 trial, OASIZ 303, is expected to complete in the fourth quarter of 2026.
Immunovant, a majority-owned Roivant subsidiary, reported on September 23, 2026 that a 57-patient randomized, double-blind, placebo-controlled proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus did not reach statistical significance on percent change in CLASI-A score at week 12. The company reported numerical trends favoring the drug and an association between deeper IgG reductions and clinical response, but said the results did not meet its internal bar and it will stop development in the indication. Trials of the FcRn inhibitor continue in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, CIDP, and Sjögren's disease.
Celldex Therapeutics reported on Tuesday, September 22, 2026 that both Phase 3 trials of barzolvolimab, a humanized monoclonal antibody that binds the KIT receptor on mast cells, met their primary endpoint of mean change in weekly urticaria activity score (UAS7) at week 12 in adults with chronic spontaneous urticaria who remained symptomatic on H1 antihistamines. EMBARQ-CSU1 randomized 963 patients and EMBARQ-CSU2 randomized 976, for 1,939 in total. UAS7 fell by 19.7 to 20.5 points on the two barzolvolimab regimens (150 mg every 4 weeks or 300 mg every 8 weeks) versus 10.7 and 11.4 points on placebo, and complete response (UAS7 of 0) rates were 42.1% to 45.7% versus 9.3% and 12.6% on placebo. All key secondary endpoints were met, benefit was reported in omalizumab-refractory patients, and the drug was well tolerated through 24 weeks. Treatment continues to 52 weeks, and Celldex plans to file a Biologics License Application in 2027.
Viking Therapeutics reported on Tuesday, September 22, 2026 topline results from a double-blind, placebo-controlled maintenance study of VK2735, its dual GLP-1/GIP receptor agonist, in about 180 adults with a BMI of 30 or higher. After 21 weeks of weekly dosing, placebo-adjusted weight loss was 16% to 19% across VK2735 cohorts; an exploratory cohort on 17.5 mg weekly (n=13) reached about 22% weight loss from baseline at week 33. In the 12-week randomized maintenance phase, every-other-week dosing kept up to 97% of mean weight loss and monthly dosing up to 90%, compared with 61% for patients switched to placebo. Viking said gastrointestinal adverse event rates during maintenance were similar to placebo, and it plans a second part of the study to test oral maintenance regimens.
Cue Biopharma announced on Sunday, September 20, 2026 topline results from a Phase 2 trial in China of CUE-221, a humanized anti-IgE IgG1 monoclonal antibody that the company says also reduces IgE synthesis, in 145 patients with moderate-to-severe chronic spontaneous urticaria. Patients were randomized to one of three CUE-221 doses, placebo, or omalizumab 300 mg every four weeks. At week 12, complete hive resolution (HSS7 of 0) was reached by 54%, 53%, and 43% of patients on the 4, 2, and 1 mg/kg doses, versus 11% on placebo and 41% on omalizumab. There were no treatment-related serious adverse events and no hypersensitivity reactions. Cue, which licensed CUE-221 from Ascendant Health, plans a Phase 2b/3 study in chronic spontaneous urticaria and a Phase 2 study in food allergy.
Beacon Therapeutics reported on Monday, September 21, 2026 that the Phase 2/3 VISTA trial of laruparetigene zovaparvovec (laru-zova), an AAV-based gene therapy that delivers full-length RPGR, met its primary endpoint in X-linked retinitis pigmentosa (XLRP). At month 12, 31.0% of high-dose and 24.1% of low-dose patients had at least a 15-letter improvement in low-luminance visual acuity, versus no patients in the untreated control group, in a trial of 85 males aged 12 to 48. Beacon says no other late-stage XLRP trial has met its primary endpoint, and it reported a favorable safety profile with mostly mild-to-moderate ocular adverse events. The company plans a rolling BLA submission later this year and will present more data at the AAO annual meeting on October 10, 2026; it cites XLRP prevalence of about 1 in 25,000 males. Syncona is among Beacon's investors.
Roche announced on Thursday, September 17, 2026 that the Phase 3 CELESTIMO trial met its primary endpoint: Lunsumio (mosunetuzumab) plus lenalidomide produced a statistically significant improvement in progression-free survival versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. Overall survival data were immature at the interim analysis, and safety was consistent with the known profiles of both drugs, with no new signals. CELESTIMO is the confirmatory study required to convert the accelerated approval and conditional authorization of Lunsumio monotherapy for third-line or later follicular lymphoma into full approval. Roche will submit the data to health authorities and present them at an upcoming medical meeting.
Vera Therapeutics reported on Tuesday, September 15, 2026 final efficacy results from the Phase 3 ORIGIN 3 trial of TRUTAKNA (atacicept-vymj) in 428 adults with primary IgA nephropathy at risk of progression. At 52 weeks, mean eGFR changed by -0.1 mL/min/1.73m² on TRUTAKNA versus -5.7 on placebo, and the annualized eGFR slope through 104 weeks was -0.6 versus -5.6 mL/min/1.73m² per year. TRUTAKNA cut the risk of composite kidney disease progression by 76% (hazard ratio 0.24; 11 versus 38 events), with no dialysis, transplant, or death events versus 8 on placebo, and proteinuria, galactose-deficient IgA1, and hematuria also fell significantly. Safety was generally comparable to placebo. Vera plans to submit a supplemental BLA for full approval in the fourth quarter of 2026 and reported more than 350 patient start forms in the first ten weeks of launch.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced Monday September 14, 2026 positive topline results from the Phase 1b CANYON-1 trial evaluating CRB-913 (once-daily oral peripherally-restricted CB1 inverse agonist for obesity) in 254 obese non-diabetic U.S. adults across 15 sites (NCT07310901). Mean weight loss at 12 weeks: 5.0% at 60 mg (n=62), 3.3% at 40 mg (n=61), 2.8% at 20 mg (n=65) versus 0.0% on placebo (n=66) — all p<0.0001. No plateau was observed at any dose. Discontinuation rates ranged 3.1-13.1% across doses (comparable to 6.9-20.7% for oral GLP-1s in cross-trial comparison). At the 60 mg dose: nausea 22.6%, diarrhea 22.6%, constipation 4.8%, vomiting 1.6%. Psychiatric adverse events at 60 mg: depression 1.6%, anxiety 4.8%, irritability 9.7%, insomnia 0% — no serious psychiatric events or suicidality reported. CRB-913 was designed with approximately 15-fold lower brain penetration than monlunabant in preclinical models to preserve CB1-driven weight loss while limiting the psychiatric side effects that led to the 2008 withdrawal of Sanofi's Acomplia (rimonabant). CRBP shares closed up 12% on the day. Next steps: FDA clinical development plan engagement, Phase 2 monotherapy trial initiation in H1 2027, evaluation of a GLP-1 combination approach, and full data presentation at ObesityWeek 2026 (November 14-17, Washington DC).
Corbus Pharmaceuticals (NASDAQ: CRBP) enters Sunday September 13, 2026 the final day of the countdown to Monday September 14 at 8:00 a.m. EDT conference call disclosing Phase 1b CANYON-1 topline data for CRB-913 (once-daily oral peripherally-restricted CB1 inverse agonist for obesity). The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults across once-daily doses of 20 mg, 40 mg, and 60 mg (titrated from 20 mg over four weeks) with a 4-week safety follow-up (NCT07310901). Harold Bays MD (investigator) joins Corbus management. Investor focus is on the CB1 inverse agonist class safety-versus-efficacy trade-off: peripheral restriction (approximately 15-fold lower brain penetration than monlunabant in preclinical models) is designed to preserve dose-responsive weight loss while limiting the psychiatric side effects that led to the 2008 withdrawal of Sanofi's Acomplia (rimonabant). Corbus previously reported Phase 1a mean 2.9% placebo-adjusted weight loss by Day 14. Clean tolerability plus dose-responsive weight loss would enable Phase 2 initiation and position CRB-913 as one of the earliest non-incretin oral obesity options alongside Novo Nordisk cagrilintide (amylin), Structure Therapeutics aleniglipron (oral small-molecule GLP-1), and the Roche petrelintide-enicepatide combo Phase 2.