Peptide News Digest

Clinical Trials News

276 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.

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Journal of Nuclear Medicine: 195-Patient Study Finds SSTR Expression Largely Retained After PRRT Progression, Supporting Retreatment

A Journal of Nuclear Medicine study analyzed patterns of progression in 195 patients with gastroenteropancreatic neuroendocrine tumors treated with [177Lu]Lu-DOTATATE PRRT. Progression occurred in 107 patients (54.9%), most often in the liver (60.7%) followed by bone (25.3%). Post-progression somatostatin receptor PET imaging showed retained SSTR uptake in 59.7% of patients, increased uptake in 18.2%, and reduced uptake in 19.5%, indicating that the majority remain candidates for additional SSTR-targeted radioligand therapy. The dataset reinforces the clinical case for sequencing peptide radioligand therapies rather than abandoning the modality at first progression.

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Zealand Pharma and Roche Formally Endorse Petrelintide for Phase 3 Trials in Chronic Weight Management

Zealand Pharma announced April 29 that it and partner Roche have formally endorsed advancing petrelintide — a long-acting amylin analog suitable for once-weekly subcutaneous administration — into Phase 3 trials for chronic weight management, with initiation planned for H2 2026. The Phase 3 program will evaluate petrelintide as monotherapy and in combination with Roche's GLP-1/GIP receptor dual agonist enicepatide (CT-388). The decision follows positive Phase 2 ZUPREME-1 data showing up to 10.7% weight loss with placebo-like tolerability; petrelintide is now positioned as the lead non-GLP-1 obesity asset behind only Novo's CagriSema.

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Rein Therapeutics LTI-03 Phase 2 RENEW Trial Update: 8 Patients Enrolled in Idiopathic Pulmonary Fibrosis Study

Rein Therapeutics announced April 29 a clinical update for its Phase 2 RENEW trial of LTI-03 — a peptide therapeutic for idiopathic pulmonary fibrosis (IPF). 8 patients have been enrolled to date, with 2 additional patients expected to be enrolled this week. Enrollment began March 2026 and continues steadily. LTI-03 is one of the few peptide candidates in the IPF space, where current standards of care (pirfenidone, nintedanib) have meaningful tolerability limits. The peptide-based approach is mechanistically distinct, targeting Caveolin-1-related fibrotic pathways.

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Nature Medicine: AMPLIFY-201 Final Results — ELI-002 2P KRAS Amphiphile Vaccine Delivers Durable Relapse-Free Survival in Pancreatic and Colorectal Cancer

Final phase 1 AMPLIFY-201 results published in Nature Medicine report that ELI-002 2P — a lymph node-targeted vaccine combining amphiphile-modified mutant KRAS G12D/G12R peptides with CpG-7909 adjuvant — produced durable responses in 25 patients with minimal residual mKRAS disease (20 pancreatic, 5 colorectal). At 19.7 months median follow-up, robust T-cell responders achieved median relapse-free survival not reached vs. 3.02 months in non-responders (HR 0.12, p=0.0002); 71% of evaluable patients generated both CD4+ and CD8+ T cells, and antigen spreading was observed in 67%. Phase 2 enrollment of the next-generation 7-peptide formulation ELI-002 7P is complete, with results expected in 2026.

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Boehringer Ingelheim and Zealand Pharma Announce Phase 3 SYNCHRONIZE-1 Topline: Survodutide Achieves 16.6% Weight Loss at 76 Weeks

Boehringer Ingelheim and Zealand Pharma announced positive topline results from the Phase 3 SYNCHRONIZE-1 trial of survodutide (BI 456906), a glucagon/GLP-1 dual agonist, in adults with obesity or overweight without type 2 diabetes. Adults treated with survodutide achieved 16.6% mean weight loss at 76 weeks (efficacy estimand) versus 3.2% placebo (p<0.0001), with up to 85.1% of treated adults achieving ≥5% weight reduction. Up to 39.2 lb (17.8 kg) average weight loss; initial analysis indicates predominantly fat-tissue loss with lean mass contributing only a small proportion. Full data will be presented at ADA 2026 in June.

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Boehringer Advances BI 3034701: Gubra-Originated First-in-Class Triple GLP-1/GIP/NPY2 Agonist Heading to Phase 2 in Mid-2026

Boehringer Ingelheim disclosed alongside the survodutide topline that BI 3034701, a first-in-class triple GLP-1/GIP/NPY2 receptor agonist peptide, will enter Phase 2 in mid-2026. The compound completed a randomized placebo-controlled Phase 1 study in healthy volunteers and people with overweight/obesity that demonstrated favorable safety and tolerability and encouraging weight loss. BI 3034701 was developed in collaboration with Gubra, with Boehringer responsible for further development and global commercialization. The novel NPY2 component targets satiety pathways complementary to incretin agonism — a meaningful mechanistic differentiation in the next-gen obesity pipeline.

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Scholar Rock Apitegromab + Tirzepatide EMBRAZE Phase 2: 54.9% Lean Mass Preservation Continues to Set Muscle-Sparing Bar

Scholar Rock's apitegromab — a selective pro/latent myostatin antibody approved for SMA — continues to draw obesity-pipeline attention with EMBRAZE Phase 2 data showing 54.9% relative lean mass preservation when combined with tirzepatide vs tirzepatide alone (4.2 lbs / 1.9 kg additional lean mass preserved, p=0.001). Body composition shifted from 70% fat/30% lean with tirzepatide alone to 85%/15% with the combination. SRK-439 next-gen selective myostatin inhibitor is in preclinical development with attenuation of fat-mass rebound after GLP-1 withdrawal as a key signal.

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Regeneron COURAGE Phase 2: Trevogrumab + Semaglutide Doublet Cuts Lean Mass Loss in Half; Triplet with Garetosmab Pushes to 92.6% Fat-Mass Loss

Regeneron's COURAGE Phase 2 data presented at EASD 2025 continue to drive obesity-pipeline conversations. Semaglutide alone produced 6.5% lean mass loss at 26 weeks; sema + trevogrumab 200 mg cut that to 3.3% (~half), and the triplet with garetosmab (anti-activin A) pushed to 2.0% lean mass loss with 92.6% fat-mass loss. The triplet had higher discontinuation for tolerability. Full COURAGE completion is expected late 2026, with Phase 3 initiation likely 2027.

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Boehringer Ingelheim Survodutide SYNCHRONIZE-1 Phase 3: 76-Week Primary Endpoint Visit Complete, Topline Data Expected H1 2026

Boehringer Ingelheim confirmed completion of the 76-week primary endpoint visit for the last participant in Phase 3 SYNCHRONIZE-1. Topline data expected H1 2026 — making it one of the year's most anticipated obesity readouts. Survodutide is a glucagon/GLP-1 dual agonist co-developed with Zealand Pharma. The comprehensive SYNCHRONIZE program also includes SYNCHRONIZE-CVOT (cardiovascular outcomes, fully enrolled). All key trials are scheduled to read out at scientific meetings throughout 2026, potentially paving the way for regulatory submission as the third major obesity GLP-1-class drug after semaglutide and tirzepatide.

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Liraglutide ELAD Phase 2b in Mild-to-Moderate Alzheimer's: Multicenter RCT Continues Driving GLP-1 Neurology Discussion

The ELAD trial — a multicenter, randomized, double-blind, placebo-controlled Phase 2b study of liraglutide in 204 mild-to-moderate Alzheimer's disease participants — published in Nature Medicine (online December 2025) continues to drive clinical-research discussions about GLP-1s in neurodegeneration. Coming after the Phase 3 EVOKE trials' negative cognition results, ELAD's intermediate-stage findings are being parsed for endpoints, mechanisms, and biomarker patterns that may guide future trial design in this contested indication.

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Crinetics CRN09682 First-in-Class SSTR2 Non-Peptide Drug Conjugate Reported — Direct Challenge to Peptide-Based PRRT

BioWorld reported April 24 on Crinetics Pharmaceuticals' CRN09682, a first-in-class non-peptide drug conjugate (NDC) coupling a small-molecule somatostatin receptor 2 (SST2) agonist to monomethyl auristatin E (MMAE) via a cleavable linker. The compound is in Phase 1/2 BRAVESST2 trial in metastatic neuroendocrine tumors and other SST2-expressing solid tumors — directly competing with peptide-radioconjugate therapies like Novartis' Lutathera and Perspective Therapeutics' alpha-PRRT. The non-peptide approach trades off receptor-binding peptide selectivity for small-molecule manufacturing simplicity.

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FDA Approves Sanofi's Tzield (Teplizumab) for Children Down to Age 1 in Stage 2 Type 1 Diabetes — First Disease-Modifying Therapy for Pediatric T1D

Sanofi announced April 22 FDA approval of an expanded Tzield (teplizumab-mzwv) indication for stage 2 type 1 diabetes patients as young as 1 year old, down from the previous 8-and-up indication. The approval was supported by 1-year data from the PETITE-T1D Phase 4 study (n=23, mean age 4.8 years), showing 89.6% probability of remaining stage-3-progression-free at 1 year. Tzield delays progression from stage 2 to stage 3 T1D by an average of 2 years and is the first disease-modifying therapy for autoimmune T1D — relevant to the broader insulin/peptide endocrinology landscape.

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Novo Nordisk PIONEER TEENS Phase 3a Trial: Oral Semaglutide Shows Superior HbA1c Reduction in Children and Adolescents with Type 2 Diabetes

Novo Nordisk announced April 23 positive topline results from the PIONEER TEENS trial: a 52-week, randomized, double-blind, placebo-controlled Phase 3a study of oral semaglutide (3, 7, or 14 mg once daily) in 132 children and adolescents aged 10-17 with type 2 diabetes. Oral semaglutide reduced HbA1c by 0.83 percentage points more than placebo at 26 weeks with a well-tolerated safety profile. Pending regulatory approvals, it would be the first oral GLP-1 RA for this pediatric population. Novo expects to file for label expansion in the US and EU in H2 2026.

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Fractyl Health REMAIN-1 Midpoint Cohort Data: Revita Duodenal Mucosal Resurfacing Cuts Post-Tirzepatide Weight Regain by 40% — Accepted for DDW 2026

Fractyl Health's REMAIN-1 study — the first blinded, randomized, sham-controlled trial of an endoscopic 'gut reset' procedure — was accepted for presentation at DDW 2026. In 45 adults who had lost ≥15% body weight on tirzepatide and then discontinued, 29 received Revita duodenal mucosal resurfacing and 16 had a sham procedure. At 6 months post-discontinuation, Revita-treated patients regained 4.5% vs 7.5% for sham (P=0.07) — a 40% lower weight regain. Patients with more tissue resurfaced maintained >80% of pre-discontinuation weight loss. Topline pivotal-cohort data expected Q4 2026.

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Bicycle Therapeutics Announces ASCO 2026 Oral and Poster Program for Nuzefatide Pevedotin (BT5528) Across Multiple Tumor Types

Bicycle Therapeutics announced April 21 its program for the 2026 ASCO Annual Meeting (May 29-June 2 in Chicago), with an oral presentation and five poster abstracts on nuzefatide pevedotin — its EphA2-targeting bicyclic peptide drug conjugate. Key data from Phase 1/2 include the recently disclosed 40% ORR in checkpoint-refractory urothelial cancer, expanded head-and-neck squamous cell carcinoma preclinical data, and the selected 8mg/m² Q2W dose for the Phase 2 recurrent pancreatic cancer trial. The program solidifies Nuzefatide's positioning as a leading bicyclic peptide drug conjugate in oncology.

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Bicycle Therapeutics Reports First-in-Human EphA2 Bicyclic Peptide Gallium-68 PET Imaging Data in Pancreatic Cancer at AACR 2026 Finale

On the final day of AACR 2026, the German Cancer Consortium presented first-in-human imaging data for EphA2 BIA — a gallium-68-labeled bicyclic peptide targeting EphA2 — in pancreatic ductal adenocarcinoma patients. Seven patients underwent PET/CT imaging up to three hours post-injection, with rapid tumor uptake and primarily renal excretion in six of seven. The tracer successfully detected liver, bone, lymph node, and peritoneal metastases in 15 of 18 patients imaged to date, validating bicyclic peptides as a radioconjugate imaging modality.

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Neurocrine Biosciences Presents Two-Year CRENESSITY Phase 3 Data at AACE 2026: 38% Glucocorticoid Dose Reduction in Classic CAH

Neurocrine Biosciences announced April 22 two-year data from the Phase 3 CAHtalyst Adult study at AACE 2026 in Las Vegas. CRENESSITY (crinecerfont), a CRF1 receptor antagonist that dampens the CRF-ACTH peptide signaling axis, achieved sustained glucocorticoid dose reductions in adults with classic congenital adrenal hyperplasia: mean daily GC dose decreased from 17.6 to 10.6 mg/m²/day HCe (−38%), and approximately 69% of patients achieved GC doses within the physiologic range while maintaining androgen control. No new safety signals emerged.

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Evaxion EVX-01 Personalized Peptide Vaccine Achieves 75% ORR at 2 Years in Metastatic Melanoma

Evaxion's AI-designed personalized neoantigen peptide vaccine EVX-01 combined with Keytruda produced a 75% objective response rate at 2 years in advanced melanoma patients, with 86% of vaccine targets triggering de novo T-cell responses. Data were presented April 22 at AACR 2026; 3-year follow-up expected in H2 2026. The 86% target-hit rate demonstrates AI-designed peptide neoantigen selection maturing for cancer vaccines.