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Company

Boehringer Ingelheim

Survodutide. Dual agonist in development for obesity and MASH.

7 signals

Market access

DrugIndicationBrazilChinaFranceGermanyItalyJapanKoreaMexicoSpainUAEUKUS
Jardiance
empagliflozin
CKD--
Jardiance
empagliflozin
T2D
Jardiance
empagliflozin
heart failure

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Disease Area

Source

7 of 7 signals

ClinicalTrials16 Apr 2026·Phase 3● 7/10i

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

Boehringer Ingelheim is testing survodutide, a weekly injectable, versus placebo in 1,800 adults with MASH and moderate to advanced liver fibrosis (F2-F3). This placebo-controlled trial runs up to 7 years with dual primary endpoints: MASH resolution without fibrosis worsening and composite clinical outcomes including progression to cirrhosis. This positions Boehringer as the first major pharma to advance a dedicated MASH program into Phase 3, targeting a liver indication where Novo's semaglutide and Eli Lilly's tirzepatide have shown promise but lack specific approvals. The 7-year duration reflects the extended timeline needed to demonstrate meaningful liver outcomes in this progressive disease.

Liver/NASHGLP-1Boehringer Ingelheim
ClinicalTrials16 Apr 2026·Phase 3● 7/10i

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

Boehringer Ingelheim is testing survodutide, a once-weekly injectable, in people with compensated NASH/MASH cirrhosis in a phase 3 trial targeting liver-related clinical outcomes. The randomized, placebo-controlled study aims to enroll 1,590 participants over 4.5 years, measuring time to death, liver transplant, hepatic decompensation, or disease progression. This represents Boehringer's entry into the competitive NASH space where Novo Nordisk's semaglutide is already in phase 3 trials for non-cirrhotic NASH. The trial focuses on advanced cirrhotic patients, a population with high unmet need but challenging regulatory pathway.

PubMed14 Apr 2026·Annals of internal medicine● 3/10i

Nephrology: What You May Have Missed in 2025.

Finerenone plus empagliflozin combination data emerged alongside other nephrology findings including AI models for AKI prediction and interventions for patients on dialysis. Annual review article covering multiple 2025 nephrology studies across AKI management, kidney function factors, and dialysis complications. This provides the first mention of dual finerenone-empagliflozin use data, potentially signaling combination therapy development in chronic kidney disease.

PubMed13 Apr 2026·The lancet. Gastroenterology & hepatology● 6/10i

Global burden of metabolic dysfunction-associated steatotic liver disease, 1990-2023, and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2023.

MASLD prevalence reached 1.3 billion people globally in 2023 (16.1% of population), with cases projected to rise 42% to 1.8 billion by 2050. Global Burden of Disease systematic analysis covering 204 countries from 1990-2023 with forecasting to 2050. This provides the first comprehensive global epidemiological baseline for MASLD, quantifying the massive addressable patient population for emerging therapies like survodutide and semaglutide. High fasting glucose emerged as the largest modifiable risk factor, followed by high BMI.

ClinicalTrials2 Apr 2026·Phase 3● 7/10i

A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes Mellitus

Boehringer Ingelheim's survodutide (BI 456906) is being tested in a placebo-controlled phase 3 trial for weight loss in adults with overweight or obesity and type 2 diabetes. The 76-week study enrolled 755 participants randomized 2:1 active to placebo, measuring percentage weight loss and achievement of ≥5% weight reduction. This positions Boehringer as a potential third major player in the GLP-1 obesity market, currently dominated by Novo Nordisk's Wegovy and Eli Lilly's Zepbound. The trial completion in December 2025 could establish survodutide as another weekly injectable option for people with diabetes and obesity.

GLP-1Weight lossType 2 diabetesBoehringer Ingelheim
ClinicalTrials2 Apr 2026·Phase 3● 7/10i

A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD

A phase 3 cardiovascular outcomes trial is testing survodutide (BI 456906), a dual GLP-1/glucagon receptor agonist, in 5,533 adults with overweight or obesity and established cardiovascular disease or chronic kidney disease. The randomized, double-blind, placebo-controlled study compares two doses of once-weekly subcutaneous survodutide against placebo over up to 2.25 years. This represents Boehringer Ingelheim's entry into the competitive obesity market with a differentiated dual mechanism approach. The trial aims to demonstrate cardiovascular safety non-inferiority, a regulatory requirement for obesity drugs in high-risk populations.

GLP-1Weight lossCardiovascularBoehringer Ingelheim
PubMed1 Apr 2026·Diabetes, obesity & metabolism● 4/10i

Effect of empagliflozin on urinary albumin excretion and hypoxic biomarkers in early diabetic kidney disease: A randomised double-blind, placebo-controlled trial.

Empagliflozin showed a declining trend in albumin creatinine ratio versus placebo but failed to reach statistical significance at 24 weeks in adults with type 2 diabetes and microalbuminuria. Randomized controlled trial of 79 patients over 24 weeks comparing empagliflozin 10mg daily to placebo. This provides new mechanistic insight into SGLT2 inhibitor kidney protection through suppression of hypoxia-induced angiogenic factors VEGF and ANGPTL2, offering biological explanation for established renal benefits. The primary endpoint missed statistical significance despite early positive trends.

SGLT2Type 2 diabetesKidneyBoehringer IngelheimEli Lilly

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