Peptide News Digest

Clinical Trials News

229 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.

· View digest

CagriSema REDEFINE 1 ASCVD Risk + hsCRP + SBP Sub-analyses Presented ECO 2026 Day 3 (May 14)

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.

· View digest

RESETTLE Trial (ECO 2026 May 13): Semaglutide 2.4 mg in 18-28 Year Olds With Treatment-Resistant Severe Obesity Drives 19% Mean BMI Reduction

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.

· View digest

Innovent Mazdutide Announces Full ADA 2026 Slate (May 12) — Phase 3 GLORY-2 18.55% Weight Loss + DREAMS-3 vs Semaglutide Head-to-Head

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.

· View digest

Eli Lilly Joint Publication May 12: SURMOUNT-MAINTAIN (Lancet) + ATTAIN-MAINTAIN (Nature Medicine) — Both Trials Confirm Weight Maintenance After Switch from Maximum-Tolerated Injectable Doses

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.

· View digest

Viking Therapeutics VK2735 Oral Phase 2 VENTURE-Oral Full 13-Week Data (May 12 ECO): 12.2% Mean Weight Loss (26.6 lbs) Dose-Dependent, Week 1 Onset

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.

· View digest

Novo Wegovy Pill OASIS 4 Subanalyses at ECO 2026 (May 13): 21.6% Body Weight Loss in Early Responders + 77.3% Achieve Mobility Improvement

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.

· View digest

PepGen Pivots to DM1: Discontinues DMD Program After 10 mg/kg PGN-EDO51 Delivers Only 0.59% Dystrophin, Focuses on FREEDOM2-DM1 Phase 2

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.

· View digest

CagriSema REDEFINE 1 BMI + Waist-to-Height Ratio Treatment Targets at ECO 2026 (May 12): 50.7% of Treated Patients Reach BMI <30 vs 10.2% Placebo

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).

· View digest

Novo Nordisk ECO 2026 (May 12): Higher-Dose Wegovy 7.2 mg Drives 28% Weight Loss in Early Responders — 27% of Patients Cross the 15%-at-24-Week Threshold

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.

· View digest

Novo Nordisk ECO 2026 (May 12): Wegovy Weight Loss Independent of Menopausal Stage + 34,000-Woman Real-World Database Shows 42-45% Migraine and 25% Depression Risk Reduction

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.

· View digest

CagriSema REDEFINE 1 Body Composition Substudy at ECO 2026: 35.7% Fat Mass Loss vs 14.4% Lean Tissue Loss in 252 Patients

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.

· View digest

Tonix Pharmaceuticals Q1 2026: TONMYA Hits $3.7M Launch Revenue, TNX-1900 Intranasal Oxytocin Pipeline Spans Binge Eating, Adolescent Obesity, Bone Health, AVP Deficiency

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.

· View digest

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.

· View digest

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.

· View digest

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.

· View digest

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.

· View digest

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.

· View digest

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.