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.
Eli Lilly announced TRIUMPH-1 topline results May 21 from the 80-week Phase 3 registrational trial of retatrutide — a first-in-class GIP/GLP-1/glucagon triple-receptor agonist — in 2,339 adults with obesity or overweight and at least one weight-related comorbidity, without diabetes. Mean body weight loss was 28.3% (70.3 lbs) at 12 mg, 25.9% at 9 mg, and 19.0% at 4 mg, all versus 2.2% on placebo. All three doses met the primary and key secondary endpoints. 45.3% of participants achieved ≥30% weight loss — bariatric-surgery territory. A 104-week extension in adults with baseline BMI ≥35 saw mean weight loss reach 30.3% (85.0 lbs) on 12 mg. Full data presentation is scheduled for ADA 2026 in New Orleans (June 5-8). Lilly's NDA filing follows the TRIUMPH-2 (obesity + T2D) and TRIUMPH-3 (obesity + established cardiovascular disease) readouts expected later in 2026.
TRIUMPH-1's safety profile landed alongside the efficacy headline. Discontinuation rates due to adverse events were 4.1%, 6.9%, and 11.3% on retatrutide 4 mg, 9 mg, and 12 mg respectively, versus 4.9% on placebo. The most common adverse events were nausea, diarrhea, constipation, and vomiting — generally mild-to-moderate, concentrated during dose escalation, and decreasing over time. The hepatic-enzyme signal that appeared in TRIUMPH-4 (December 2025) reappeared as transient ALT elevations in a subset of participants on 9 mg and 12 mg dosing, normalizing by week 24. Liver fat dropped >80% on 8-12 mg dosing, supporting the interpretation that the transient transaminitis reflects hepatic triglyceride mobilization rather than hepatotoxicity. The 12 mg discontinuation rate at 11.3% sits modestly above tirzepatide 15 mg in SURMOUNT-1 (~7%) and Wegovy 2.4 mg in STEP 1 (~6.5%) — a tolerability gap that prescribers and patients will weigh against the efficacy gain.
Novo Nordisk's AMAZE-12 Phase 3 trial of amycretin — a dual GLP-1 and amylin receptor agonist — began recruiting on May 18, 2026. The trial evaluates amycretin specifically for weight maintenance after initial weight loss, distinguishing it from AMAZE-1 (which measures body weight change over 84 weeks). The amycretin clinical rationale rests on Phase 1 weekly subcutaneous dosing producing 22% weight reduction at 36 weeks and oral formulation producing 13.1% at 12 weeks — both reported in the Lancet earlier in 2026. Amycretin sits within Novo's next-generation pipeline alongside CagriSema (cagrilintide + semaglutide, FDA filing under review with decision expected late 2026) and the orexin-related pipeline acquired via Centessa. The amycretin program is structurally Novo's most direct response to Lilly's retatrutide.
Avacta's AVA6000 — a fibroblast activation protein (FAP)-activated peptide-drug conjugate releasing doxorubicin selectively in the tumor microenvironment — released Phase 1a/1b data at ASCO 2026 in salivary gland cancers. Of 30 patients in the Phase 1b cohort treated at 250 mg/m² and above, two experienced confirmed partial responses (>30% tumor shrinkage) and seven experienced minor responses (10-30% shrinkage). The combined Phase 1a + 1b disease control rate reached 90%. Phase 1a data in 11 patients at the same dose range showed 1 confirmed partial response, 4 minor responses, 1 progression, and 5 stable disease — a 91% disease control rate. The favorable safety profile continued versus conventional doxorubicin, with no severe cardiac toxicity events. The data anchors Avacta's planned Phase 2/3 expansion in adenoid cystic carcinoma — the most common salivary gland cancer subtype, with no FDA-approved systemic therapy.
Bicycle Therapeutics released Duravelo-2 Phase 2/3 interim analysis data at ASCO 2026 — zelenectide pevedotin (BT8009, a Nectin-4-targeting bicyclic peptide-MMAE conjugate) plus pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer. The full data presentation is scheduled for Monday June 1, 8:30-8:36 AM CT in the GU Cancers oral session (Abstract 4516). The Duravelo-1 monotherapy comparator anchor — 65% ORR (13/20) in cisplatin-ineligible 1L mUC at 5 mg/m² + pembrolizumab combination, with median DOR 11.1 months in the monotherapy expansion — sets the bar for what the Duravelo-2 combination interim must clear. Bicycle's five-abstract ASCO package includes the oral Duravelo-2 piece plus four posters covering Duravelo-1 monotherapy update, BT5528 EphA2 monotherapy and combination cohorts, and BT8009 second-line urothelial data.
BriaCell released final randomized Phase 2 Bria-IMT survival and quality-of-life data at ASCO 2026 alongside biomarker analyses from the ongoing Phase 3 study. Bria-IMT — a whole-cell allogeneic peptide-and-cell immunotherapy combined with checkpoint inhibitor — has been studied in heavily pretreated metastatic breast cancer patients who have failed antibody-drug conjugate, checkpoint, and CDK4/6 inhibitor therapy. The Phase 2 data set covers 12- and 24-month survival, treatment tolerability, and circulating-tumor-cell biomarker work. The Phase 3 program added Penn Medicine's Abramson Cancer Center as a site on May 13, joining Smilow Cancer Hospital at Yale New Haven and the Los Angeles Cancer Network. The six-abstract BriaCell package at ASCO 2026 — three poster presentations and three publication-only abstracts — establishes the company as the largest peptide-immunotherapy presence at this year's meeting.
Eight days ahead of EASL Congress 2026 in Barcelona (May 27-30), Novo Nordisk released new analyses from the Phase 3 ESSENCE program showing semaglutide 2.4 mg holds a favorable hepatic safety profile across MASH subgroups, including the first dedicated Japanese MASH cohort and a women-in-menopause subset. Gastrointestinal events remained the leading adverse-event signal, with small discontinuation rates. MASH affects an estimated 250 million people globally with roughly 9 in 10 cases undiagnosed; the trial data reinforce the FDA's August 2025 MASH-with-fibrosis approval and broaden the prescribing case ahead of the EASL plenaries.
An ECO 2026 analysis covered May 18 by ScienceDaily examined 89,718 patients starting GLP-1 therapy — 75.6% semaglutide, 17.5% tirzepatide, 6.9% liraglutide — and stratified BMI change at year one. In the first year, 27% reduced BMI by less than 5%, 22.4% by 5-10%, 14.1% by 10-15%, and 15.8% by ≥15%, while 20.8% actually gained weight. Greater weight loss correlated with larger reductions in obesity-related risk endpoints; patients who gained weight after starting treatment faced worse health outcomes than untreated comparators in several measures.
Avacta Therapeutics reported unaudited preliminary results for the 12 months ended December 31, 2025 on Tuesday May 19, 2026, and disclosed that the first patient received treatment in FOCUS-01 — the Phase 1 clinical trial of AVA6103, a FAP-activated exatecan peptide-drug conjugate — in March 2026. AVA6103 is the second pre|CISION-enabled candidate in the Avacta clinical pipeline, after AVA6000 (FAP-Dox, which has Phase Ia/Ib data scheduled at ASCO 2026 in salivary gland cancers). The pre|CISION platform attaches a peptide tetrazolyl moiety cleaved by FAP (fibroblast activation protein) overexpressed in cancer-associated fibroblasts, allowing systemic administration of cytotoxic payloads without the dose-limiting toxicity that constrains free exatecan. FOCUS-01 is enrolling adults with advanced solid tumors. AVA6103 expands the platform from doxorubicin (in AVA6000) to exatecan — a topoisomerase I inhibitor with potency advantages in HER2-low and triple-negative breast cancer.
MetaVia confirmed Monday May 18 that three late-breaking abstracts have been accepted at the ADA 2026 Scientific Sessions (June 5-8 New Orleans). DA-1726 is a once-weekly subcutaneous oxyntomodulin analog functioning as a GLP-1R/GCGR dual agonist for obesity and MASH; Phase 1 Part 3 higher-dose titration results will be presented, with full Phase 1 trial data expected in Q4 2026. Vanoglipel (DA-1241) is a first-in-class GPR119 agonist that promotes endogenous release of GLP-1, GIP, and PYY from the gut; the ADA poster covers synergistic preclinical effects in combination with resmetirom (Madrigal's MASH therapy) and with metformin for type 2 diabetes. The three-poster slate positions MetaVia as one of several mid-cap obesity-pipeline names with clinical data inflections clustered into the ADA + ASCO + EASD 2026 calendar.
BriaCell announced May 15 it has expanded its pipeline to include Bria-OVA+, a next-generation personalized off-the-shelf cell-based immunotherapy for ovarian cancer. The company licensed ovarian-cancer cell lines from American Type Culture Collection (ATCC) and has commenced development activities to support production of Bria-OVA+ for potential clinical use. The candidate is designed with additional immune-stimulating components to support enhanced anti-tumor activity, building on Phase 2 efficacy and tolerability data in metastatic breast cancer. The company is targeting ovarian cancer because an estimated 21,010 women in the US will be diagnosed in 2026 and approximately 12,450 will die from the disease, with ovarian cancer remaining the deadliest gynecologic cancer. The expansion adds to the BriaCell platform spanning Bria-IMT (metastatic breast), Bria-OTS+ (next-gen breast and prostate), Bria-PROS+ (prostate), and Bria-BRES+ (breast).
BriaCell announced May 14 it has completed manufacturing of clinical supplies for Bria-PROS+, the company's prostate cancer cell-based immunotherapy candidate, positioning the program for an IND filing and Phase 1/2 initiation later in 2026. On May 13, BriaCell added Penn Medicine's Abramson Cancer Center as a clinical site for the pivotal Phase 3 Bria-IMT metastatic breast cancer study, bringing the trial-site network to include Smilow Cancer Hospital at Yale New Haven and Los Angeles Cancer Network. The two announcements come ahead of BriaCell's six accepted ASCO 2026 abstract presentations on Bria-IMT and Bria-OTS+ in metastatic breast cancer, scheduled for the May 29-June 2 Chicago meeting. The May 6 FDA clearance for the Bria-BRES+ clinical study completes a busy two-week operational cadence for the company.
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.