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.
Aivocode is preparing first-in-human Phase 1 dosing for its CAQK tetrapeptide candidate in acute traumatic brain injury, building on the December 2025 EMBO Molecular Medicine paper that established the neuroprotective mechanism in rodent models. CAQK is a four-amino-acid peptide (Cys-Ala-Gln-Lys) that homes specifically to brain extracellular matrix exposed by tissue damage, enabling targeted delivery of therapeutic payloads to injured but not healthy brain regions. The preclinical data showed reduced lesion volume and improved functional recovery in mouse and rat TBI models when CAQK was conjugated to neuroprotective small molecules. The Phase 1 program — IND-enabling work ongoing — would represent one of the few peptide-based TBI candidates entering clinical testing, an indication with no FDA-approved neuroprotective therapies.
Eli Lilly's TRIUMPH program for retatrutide — a triple GIP/GLP-1/glucagon receptor agonist — has TRIUMPH-1 (general obesity without T2D, 80 weeks, 2,007 participants) and TRIUMPH-2 (obesity + T2D) reading out in Q2-Q3 2026. Both are pivotal for the planned NDA filing. The earlier TRIUMPH-4 readout in December 2025 delivered 28.7% mean weight loss at 68 weeks on 12 mg dosing with 75% knee osteoarthritis pain reduction. The full TRIUMPH program runs eight pivotal trials with >5,800 participants total: obesity, T2D, OSA, MASLD, knee OA, cardiovascular outcomes (TRIUMPH-OUTCOMES, ~10,000 patients reading out 2027), and dose-extension studies. A new safety signal noted in Phase 2 — a small uptick in mild-to-moderate hepatic enzyme elevations on 12 mg dosing — will be monitored carefully in Phase 3 readouts. Lilly's $4.5B Lebanon Indiana investment (announced May 6) targets retatrutide manufacturing capacity ahead of the 2027 approval window.
The New England Journal of Medicine published Revolution Medicines' daraxonrasib (RMC-6236) Phase 1/2 data in previously treated advanced RAS-mutated pancreatic adenocarcinoma in May 2026. In the subgroup of 26 patients with G12 mutations treated at the 300 mg dose, objective response rate hit 35% with median progression-free survival 8.5 months and median overall survival 13.1 months — outcomes meaningfully better than the historical 5-month median OS in second-line PDAC. The mechanism is unusual: daraxonrasib is an oral small molecule that acts as a molecular glue, recruiting the peptidyl-prolyl isomerase cyclophilin A to form a tri-complex with active GTP-bound mutant RAS, blocking effector binding and downstream signaling. The drug targets KRAS, HRAS, and NRAS in the on-state — a mechanistically distinct approach from Chugai's LUNA18 cyclic peptide RAS inhibitor. FDA granted Expanded Access. The cyclophilin A-mediated mechanism puts peptidyl-prolyl chemistry at the center of a major oncology readout.
The Lancet formalized SURMOUNT-MAINTAIN on May 14, 2026, the same day the trial was presented at ECO 2026 in Istanbul. The Phase 3b 112-week study from Dr. Deborah Horn and colleagues at UTHealth Houston re-randomized patients who had reached maximum tolerated dose tirzepatide to continue MTD (15 mg or 10 mg), step down to 5 mg, or switch to placebo. Patients continuing MTD were 7x more likely to maintain their weight loss than those switching to placebo; the 5 mg step-down arm was 4x more likely than placebo. At week 112, MTD continuers preserved all of their initial weight loss; 5 mg-step-down patients lost only 5.6 kg of their initial gains on average. The 'seven times more likely' framing — picked up by EurekAlert and the daily science press — is the cleanest patient-facing summary of maintenance economics published to date.
PepGen reported Q1 2026 results on May 14 with topline data from the Phase 2 FREEDOM2-DM1 5 mg/kg multiple-ascending-dose cohort. PGN-EDODM1 — the company's peptide-conjugated phosphorodiamidate morpholino oligomer for myotonic dystrophy type 1 (DM1) — produced a mean splicing correction of 7.3% in 6 treated patients vs 6.8% in 2 placebo patients, with no serious adverse events and mainly mild treatment-emergent adverse events. The 10 mg/kg cohort is fully enrolled with data expected H2 2026; the 12.5 mg/kg cohort readout is expected in 2027. PepGen received regulatory clearance to initiate FREEDOM2 sites in South Korea, Australia, and New Zealand to add to existing sites in Canada and the UK. Q1 net loss of $17.8M (vs $30.2M a year earlier); $132.3M cash supports operations through the 12.5 mg/kg MAD readout into 2H 2027. The DM1 program is PepGen's lead clinical asset following the April DMD program discontinuation; it competes with Vertex/Entrada's VX-670 cyclic peptide-oligonucleotide (GALILEO Phase 1/2, H2 2026 readout).
Crinetics also disclosed in the May 7 Q1 update that the company is on track to initiate a seamless Phase 2/3 trial of atumelnant in ACTH-dependent Cushing's syndrome in Q2 2026. The trial will assess efficacy in a broad population including Cushing's disease and ectopic ACTH syndrome. Atumelnant is also in Phase 3 for congenital adrenal hyperplasia. Separately, Crinetics announced an exclusive license agreement with Ohio University to develop an early-preclinical growth hormone receptor antagonist (GHRA) for acromegaly — a mechanism complementary to paltusotine's SST2 agonism that would compete in the same indication once both reach market.
Novo Nordisk's CagriSema REDEFINE 1 cardiovascular sub-analyses, presented at ECO 2026 on Thursday May 14, layered onto the May 12 body-composition data. At week 68, CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) reduced systolic blood pressure by 10.9 mmHg vs 8.8 with semaglutide alone and 2.1 with placebo. High-sensitivity C-reactive protein dropped 68.9% vs 55.4% (semaglutide) and 16.0% (placebo). The 10-year predicted atherosclerotic cardiovascular disease risk decreased meaningfully on CagriSema versus all comparators, with fewer participants on CagriSema falling into the intermediate-to-high-risk category. The sub-analyses sharpen the combination-therapy case beyond the 22.7% mean weight-loss headline.
Prof. Jens-Christian Holm and colleagues at the Children's Obesity Clinic (European Centre for Obesity Management at Holbæk Hospital) presented RESETTLE at ECO 2026 on May 13. The randomized trial enrolled young adults aged 18-28 who remained severely obese despite at least one year of hospital-based non-pharmacological treatment in childhood. After 68 weeks of once-weekly semaglutide 2.4 mg vs placebo, the treatment arm achieved 19% mean BMI reduction (22.3 kg average weight loss). Total fat mass, abdominal fat, and liver fat all improved substantially vs placebo. The data fills a clinical gap — most semaglutide weight-loss trials excluded young adults coming out of structured pediatric obesity programs, leaving prescribers without evidence for one of the most underserved cohorts.
Innovent Biologics announced May 12 that it will present multiple clinical and preclinical results from mazdutide and its next-generation obesity & metabolic pipeline at the 2026 American Diabetes Association Scientific Sessions in New Orleans, June 5-8. Mazdutide is a GLP-1/glucagon dual agonist developed initially for the Chinese market. The Phase 3 GLORY-2 trial in Chinese adults with moderate-to-severe obesity reported a mean 18.55% weight reduction at 60 weeks on 9 mg dosing (vs ~3% placebo); 44% of GLORY-2 patients hit ≥20% body weight loss vs 2.5% on placebo. The Phase 3 head-to-head DREAMS-3 trial in T2D + obesity showed 48% of mazdutide patients hit HbA1c <7% + ≥10% weight loss vs 21% on semaglutide at week 32. The 9 mg dose is under NMPA review for approval in China. Mazdutide is the leading non-Lilly dual GLP-1/glucagon program competing with Boehringer's survodutide and earlier-stage Western programs.
Eli Lilly published SURMOUNT-MAINTAIN in The Lancet and ATTAIN-MAINTAIN in Nature Medicine on May 12, with concurrent presentation at ECO 2026 in Istanbul. SURMOUNT-MAINTAIN tested lower-dose Zepbound (tirzepatide 5 mg) vs maximum tolerated dose: at week 112, MTD preserved all weight loss while the 5 mg arm lost only 5.6 kg additional. ATTAIN-MAINTAIN tested Foundayo (orforglipron) as a switch from injectable GLP-1s in SURMOUNT-5 participants: orforglipron preserved 79.3% of injectable-phase weight loss vs 37.6% on placebo at week 52; Wegovy MTD switchers regained only 0.9 kg, Zepbound MTD switchers regained 5.0 kg. The dual readout reframes the maintenance-versus-discontinuation conversation: dose-tapering and oral-switching strategies now have Phase 3 evidence behind them, validating the long-term-treatment chronic-disease framing.
Viking Therapeutics presented full 13-week Phase 2 VENTURE-Oral data at ECO 2026 May 12 in Istanbul: once-daily oral VK2735 produced statistically significant, dose-dependent mean weight loss up to 12.2% (26.6 lbs) over 13 weeks with placebo-adjusted significance starting at Week 1. The favorable tolerability profile and rapid early onset of effect support Viking's Q4 2026 plan to initiate a Phase 3 trial of the oral formulation following positive FDA feedback. The data complements the Phase 3 VANQUISH-1 subcutaneous program (4,650 patients enrolled November 2025) and VANQUISH-2 in T2D+obesity (~1,000 patients, enrollment completed March 26, 2026). VK2735's dual GLP-1/GIP mechanism puts it in direct comparison with tirzepatide and the next-generation Mounjaro/Zepbound franchise.
Novo Nordisk presented new OASIS 4 subanalyses of the Wegovy pill (oral semaglutide 25 mg) at ECO 2026 on May 13. Nearly one third (29%) of patients were classified as 'early responders' — losing at least 10% body weight by week 16 — and continued treatment to 64 weeks for a mean 21.6% body weight loss vs 13.2% at four months. A separate physical function analysis showed 77.3% of patients with poor baseline physical function achieved clinically meaningful improvement (bending over, standing comfortably, staying active) vs 42.9% on placebo. The data adds to the OASIS 4 February 2026 16.6% mean weight-loss headline by stratifying patients on early response — a likely tool for prescribers thinking about dose escalation and persistence.
PepGen announced in May 2026 a strategic pivot away from Duchenne muscular dystrophy after the 10 mg/kg cohort of CONNECT1-EDO51 produced only 0.59% of normal dystrophin levels in four patients — well below the threshold of clinical meaningfulness. The company will discontinue DMD program development and focus on the FREEDOM2-DM1 Phase 2 program in myotonic dystrophy type 1, with 5 mg/kg cohort data anticipated. PepGen's Enhanced Delivery Oligonucleotide (EDO) platform conjugates peptide carriers to phosphorodiamidate morpholino oligomers (PMOs) for tissue-targeted delivery. The DM1 program competes with Vertex's VX-670 cyclic peptide-oligonucleotide conjugate (GALILEO Phase 1/2, H2 2026 readout) and Sarepta/Avidity Biosciences in the same indication.
Novo Nordisk's CagriSema REDEFINE 1 treatment-target analysis presented as an oral presentation at ECO 2026 on May 12 reported that the cagrilintide + semaglutide combination drove a higher percentage of participants to clinically meaningful BMI and waist-to-height ratio (WHtR) targets than any monotherapy or placebo arm. 50.7% of CagriSema-treated participants reached BMI <30 at week 68 vs 10.2% on placebo, and participants reaching BMI <27 plus WHtR <0.53 showed normalization of cardiometabolic parameters at higher rates than non-achievers. A companion REDEFINE 1 cardiovascular risk analysis scheduled for May 14 ECO presentation tracks predicted atherosclerotic CVD risk reduction. The data complements the May 12 body-composition substudy (35.7% fat-mass loss vs 14.4% lean tissue loss).
A post-hoc analysis of the Phase 3 STEP UP trial presented Tuesday May 12 at ECO 2026 identified an 'early responder' subgroup — patients who lost at least 15% body weight within the first 24 weeks. About 27% of patients on the higher-dose Wegovy 7.2 mg dose met that threshold vs 21% on the 2.4 mg dose and 3% on placebo. Early responders went on to lose a mean 27.7% body weight at week 72 (vs the 21% headline mean across all 7.2 mg patients). The analysis also confirmed that 84% of weight loss across both Wegovy doses came from fat mass, with muscle function preserved. The data sharpens the case for early-response-based dose decisions in the post-launch real-world workflow.
A second post-hoc analysis of STEP UP presented Tuesday found Wegovy 7.2 mg delivered consistent weight loss across reproductive life stages: 22.6% premenopausal, 19.7% perimenopausal, 19.8% postmenopausal, with 41.4% of premenopausal women hitting ≥25% loss. Waist-circumference reductions: 17.5%, 15.6%, 15.3% respectively. Separately, a real-world analysis of 34,000+ women showed that those taking Wegovy had a 42-45% lower migraine risk and a 25% lower depression risk starting six months in versus those on menopausal hormone therapy alone. The real-world data lands as observational signals that warrant prospective study — not as proof of causation — but reinforces the cardiovascular and quality-of-life narrative for the women's-health subgroup.
A prespecified body-composition substudy of REDEFINE 1 presented at ECO 2026 reported that 252 participants on CagriSema 2.4 mg/2.4 mg (semaglutide + cagrilintide) achieved a 35.7% relative reduction in fat mass and a 14.4% reduction in lean soft-tissue mass at week 68 — compared with 5.7% and 4.3% on placebo. The headline 22.7% mean weight reduction in REDEFINE 1 (NEJM publication June 2025) thus broke down with a fat-mass-to-lean-tissue ratio of roughly 2.5:1, a more favorable body-composition profile than the typical 1.5-2:1 ratio reported for GLP-1 monotherapy. The data builds the case for combination amylin-GLP-1 therapy as preferentially fat-selective.
Tonix Pharmaceuticals reported Q1 2026 May 11 with $6.9M total net product revenue and a $40.2M net loss. TONMYA (cyclobenzaprine HCl sublingual tablet for fibromyalgia) generated $3.7M in its first full commercial quarter on 5,400 prescriptions filled and 2,145 prescribing HCPs. The peptide-relevant pipeline continues to anchor on TNX-1900, an intranasal potentiated oxytocin candidate now in four Phase 2 investigator-initiated studies at Mass General Hospital and the University of Virginia: binge-eating disorder, adolescent obesity, bone health in autism spectrum disorder, and arginine vasopressin deficiency. The portfolio represents one of the few clinical-stage neuropeptide programs outside the GLP-1 axis, with potential applications across psychiatric, metabolic, and rare endocrine indications.