Clinical trial results 13 November 2026: obesity and cardiovascular risk, sleep apnoea, hepatitis delta, hidradenitis suppurativa, triglycerides and peanut allergy.
Boehringer Ingelheim’s survodutide met its cardiovascular non-inferiority endpoint in obesity. Eli Lilly’s orforglipron met its primary endpoint in obstructive sleep apnoea. Vir Biotechnology’s elebsiran and tobevibart met their primary endpoint in chronic hepatitis delta. Zura Bio’s tibulizumab missed its primary endpoint in hidradenitis suppurativa. Marea Therapeutics’ MAR001 met its primary endpoint in elevated triglycerides. Aravax’s PVX108 met its primary endpoint in peanut allergy. Here, Life Science Daily News brings you the week’s most significant readouts.
Survodutide Meets Its Cardiovascular Non-Inferiority Endpoint in the Phase 3 SYNCHRONIZE-CVOT Trial
Boehringer Ingelheim presented the SYNCHRONIZE-CVOT results for survodutide at the American Heart Association (AHA) Scientific Sessions 2026 on 9 November. The trial met its primary endpoint of non-inferiority against placebo for five-point major adverse cardiovascular events (5P-MACE). These comprised cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or heart failure events. The hazard ratio was 0.89 (95 per cent CI 0.67 to 1.18; p<0.0001 for non-inferiority), on the treatment-regimen estimand. For three-point MACE, a key secondary endpoint, it was 0.84 (95 per cent CI 0.60 to 1.18). Both intervals cross 1, so the trial shows no increase in cardiovascular risk rather than a reduction. The company makes no superiority claim. On a supplementary estimand, weight fell by up to 13.7 per cent at week 72. The figure with placebo was 2.0 per cent. Gastrointestinal adverse events led to discontinuation in 19.3 per cent (3.6 mg) and 20.8 per cent (6.0 mg) of patients. The placebo rate was 1.9 per cent.
The double-blind, event-driven trial (NCT06077864) randomised 5,530 adults with obesity or overweight. They received weekly survodutide 3.6 mg or 6.0 mg, or placebo. Participants also had established cardiovascular disease, chronic kidney disease, or at least two weight-related complications or cardiovascular risk factors. Survodutide is a glucagon and GLP-1 receptor dual agonist licensed from Zealand Pharma. Boehringer is responsible for its global development. Boehringer describes it as the first dual agonist of this kind to show a favourable cardiovascular safety profile. It attributes most discontinuations to dose escalation under the original protocol’s limited titration flexibility. The release does not state the non-inferiority margin, event numbers or follow-up duration. The results were published in The Lancet. Boehringer says it is moving forward with global regulatory submissions in obesity but gives no dates. Survodutide remains investigational. LSDN follows the class in its obesity drug news tracker.
Orforglipron Meets Its Primary Endpoint in the Phase 3 ATTAIN-OSA Programme
Eli Lilly reported the ATTAIN-OSA results for orforglipron (Foundayo) on 9 November at the AHA Scientific Sessions. The results were published simultaneously in JAMA. At 52 weeks, orforglipron met the primary endpoint, a reduction in the apnoea-hypopnoea index (AHI). In participants not using positive airway pressure (PAP) therapy, AHI fell by 21.1 events per hour from 50.7. The fall with placebo was 4.3, and the relative reductions were 43.8 per cent against 6.3 per cent. In participants on PAP, AHI fell by 18.3 events per hour from 57.6, against 5.5 with placebo. The relative reductions were 27.5 per cent against 3.0 per cent. Body weight fell by 11.5 per cent and 11.2 per cent respectively. The placebo figures were 1.8 per cent and 0.9 per cent. All figures use the efficacy estimand, and the release gives no p-values. Adverse events led to discontinuation in 12.2 per cent against 3.8 per cent without PAP. With PAP, the rates were 6.8 per cent against 0.6 per cent.
ATTAIN-OSA (NCT06649045) comprises two 52-week, randomised, double-blind, placebo-controlled studies in 712 adults. All had moderate-to-severe obstructive sleep apnoea and obesity or overweight. Study 1 enrolled 363 people unable or unwilling to use PAP, and Study 2 enrolled 349 who continued PAP. Doses were titrated to a maximum tolerated dose of 9 mg, 14.5 mg or 17.2 mg. Orforglipron is a once-daily oral small-molecule GLP-1 receptor agonist, already approved by the FDA for chronic weight management. Lilly plans to submit to the FDA for moderate-to-severe obstructive sleep apnoea by the end of 2026. The planned indication covers adults with obesity or overweight. LSDN’s GLP-1 medications list sets out where orforglipron sits among approved GLP-1 drugs.
Elebsiran and Tobevibart Meet the Primary Endpoint in the Phase 3 ECLIPSE 1 Trial
Vir Biotechnology announced topline ECLIPSE 1 results in chronic hepatitis delta on 8 November. The data were given as an oral presentation at The Liver Meeting 2026. At week 48, 44 per cent of patients given monthly elebsiran plus tobevibart met the primary endpoint. This required undetectable hepatitis delta virus (HDV) RNA together with normal alanine aminotransferase (ALT). The figure in the delayed-treatment arm was 0 per cent (p<0.0001). Undetectable HDV RNA, the key secondary endpoint, was reached by 79 per cent against 0 per cent (p<0.0001). The rate was 85 per cent in patients with cirrhosis (n=46) and 73 per cent in those without (n=37). ALT normalisation was 53 per cent against 5 per cent. The comparison arm was assessed at week 12, before it started treatment. One grade 3 treatment-related adverse event, a fall in neutrophil count, resolved within 15 days. There were no treatment interruptions or discontinuations.
The open-label ECLIPSE 1 trial (NCT06903338) randomised 124 patients 2:1 to treatment (83) or delayed treatment (41). Delayed treatment started at week 12. Elebsiran is a small interfering RNA licensed from Alnylam that targets hepatitis B virus transcripts. It is designed to reduce hepatitis B surface antigen (HBsAg) production. Tobevibart is a monoclonal antibody against HBsAg that blocks viral entry into liver cells. HBsAg below 10 IU/mL in 95 per cent against 0 per cent was an exploratory measure. ECLIPSE 2 is a switch study in patients not suppressed on bulevirtide. ECLIPSE 3 is a head-to-head trial against bulevirtide. Both are due to read out in the first quarter of 2027. Vir plans an FDA filing in mid-2027. The combination holds FDA Breakthrough Therapy and Fast Track designations, and EMA PRIME and orphan designations.
Tibulizumab Misses Its Primary Endpoint in the Phase 2 TibuSHIELD Study
Zura Bio reported that the TibuSHIELD study of tibulizumab missed its primary endpoint on 9 November. At week 16, abscess and inflammatory nodule count fell by 56.0 per cent with tibulizumab 300 mg. It fell by 58.1 per cent with 150 mg, against 52.5 per cent with placebo. No p-values were given. The key secondary endpoints were also missed. HiSCR50 response was 48.0, 52.7 and 45.5 per cent in the 300 mg, 150 mg and placebo arms. HiSCR75 response was 35.3, 34.0 and 28.1 per cent. Treatment-emergent serious adverse events occurred in 6.1, 3.7 and 1.2 per cent. One patient in the 300 mg arm died of cardiac arrest. The site investigator judged the death unrelated to treatment.
The global, randomised, double-blind, placebo-controlled study (NCT06993610) enrolled 247 adults with moderate-to-severe hidradenitis suppurativa. Patients were randomised 1:1:1. A 16-week efficacy period was followed by an optional open-label extension. Tibulizumab is designed to inhibit both IL-17 and BAFF. Zura attributes the result in part to “the high variability of placebo responses”. It is discontinuing tibulizumab in hidradenitis suppurativa and will run further analyses, including exposure-response. The TibuSURE study in systemic sclerosis continues, with topline data expected in the first half of 2027. A study in polymyalgia rheumatica is planned to start by the end of 2026.
MAR001 Meets Its Primary Endpoint in the Phase 2b TYDAL-TIMI 78 Trial
Marea Therapeutics, a subsidiary of Lisata Therapeutics, reported Part A results from TYDAL-TIMI 78 on 9 November. The data were presented as an AHA late-breaker. The results were published simultaneously in The New England Journal of Medicine. Mass General Brigham, which led the trial, also announced the findings. On the primary endpoint, placebo-adjusted fasting triglycerides at week 12 fell by 39.1, 40.9 and 45.5 per cent. These were the 300 mg, 450 mg and 900 mg doses respectively (p<0.001 for all doses). The reductions were sustained to week 24. In patients with baseline triglycerides of at least 300 mg/dL, reductions were 52.8 to 57.2 per cent. Remnant cholesterol fell by 37.3 to 40.8 per cent against placebo. The company reports no worsening of HbA1c or other glucose measures, without giving figures. Serious adverse events occurred in 2.8 per cent on MAR001 and 6.9 per cent on placebo. There was no pancreatitis and there were no deaths.
Part A randomised 235 adults with elevated triglycerides and remnant cholesterol to subcutaneous MAR001 or placebo. Doses were given every four weeks for 24 weeks. The release gives no trial identifier, and the registry lists the study as NCT07028749. MAR001 is a monoclonal antibody against ANGPTL4. Blocking ANGPTL4 is designed to increase lipoprotein lipase activity and lower triglycerides. Part B is enrolling about 100 patients with severe hypertriglyceridaemia. This is defined as fasting triglycerides of 450 to 2,000 mg/dL. Marea names MAR005, a half-life-extended version of MAR001, as its planned Phase 3 candidate. This is a lipid biomarker result and does not show a reduction in cardiovascular events.
PVX108 Meets Its Primary Endpoint in a Phase 2 Peanut Allergy Trial
Aravax announced Phase 2 results for PVX108 in peanut allergy on 12 November. In the randomised cohort of children aged 4 to 11, the 50 nmol dose met the primary endpoint. The analysis was intent-to-treat. The endpoint measured the maximum tolerated peanut dose at a double-blind, placebo-controlled food challenge. It rose 2.4-fold from baseline to month 12 with PVX108 (23 children). It rose 1.2-fold with placebo (24 children). The release reports no primary endpoint result for the 5 nmol dose. It says the signal was generally stronger at 50 nmol. A cumulative peanut protein dose of at least 443 mg was tolerated by 39.4 per cent on 50 nmol. The placebo figure was 16.7 per cent. No treatment-related allergic adverse events, including anaphylaxis, and no treatment-related serious adverse events were reported.
The trial (NCT05621317) ran at 14 sites in the United States and Australia. A pilot safety cohort of 24 adolescents came first. A double-blind efficacy cohort of 71 children then received monthly intradermal PVX108 5 nmol or 50 nmol, or placebo. Treatment lasted 12 months, and 68 completed treatment and the month 12 challenge. Aravax says PVX108 uses peptides designed to retrain the immune system to tolerate peanut. The company reports effects maintained or improved at month 18, six months after treatment stopped. The release does not say whether this follow-up was prespecified, so it should be read as exploratory. The data are topline and not peer-reviewed. Full results are due at the ACAAI Annual Scientific Meeting on 14 November. PVX108 holds FDA Fast Track designation.
Looking Ahead
This week’s clinical trial results 13 November 2026 are led by two late-stage incretin readouts. Each answers a narrower question than its headline suggests. SYNCHRONIZE-CVOT establishes that survodutide did not increase cardiovascular risk. With both confidence intervals crossing 1, it does not show cardiovascular benefit. About one in five patients on survodutide stopped because of gastrointestinal events. ATTAIN-OSA is a clear primary endpoint result for an already approved oral drug. However, the release reports efficacy estimand figures only and no p-values.
Vir’s ECLIPSE 1 is the firmest result for a new asset. It is a pivotal trial with a clear composite response and few safety signals. Its comparator, however, is untreated patients at week 12. The more demanding test, against bulevirtide, comes in ECLIPSE 3. Zura Bio’s miss is unambiguous. A high placebo response left little separation on any reported endpoint, and the company has ended the hidradenitis suppurativa programme.
The two Phase 2 results are earlier and narrower. MAR001 lowered triglycerides substantially, but that is a biomarker. The glycaemic claim also comes without figures in the release. PVX108’s result rests on a comparison of the higher dose with placebo in 47 children. Its off-treatment data are not yet peer-reviewed. Life Science Daily News will continue to cover the readouts that matter across the global life sciences pipeline.
Read the 6 November 2026 clinical trials roundup.
