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What to watch

Upcoming events and decisions that could move the market.

Q2 2026

Amgen MariTide Phase 3 readout

Phase 3 obesity trial primary endpoint data expected. Could redefine competitive landscape for injectable GLP-1 alternatives.

Amgen
Apr 2026

EMA CHMP opinion on tirzepatide CV label expansion

Expected CHMP opinion on cardiovascular indication for tirzepatide. Key reimbursement trigger in several EU5 markets.

Eli Lilly
Mid-2026

Novo Nordisk CagriSema Phase 3 obesity data

Phase 3 results for cagrilintide/semaglutide combination. Could set a new efficacy benchmark in obesity pharmacotherapy.

Novo Nordisk

Strategic Signal

Clinical Trial18 Jun 2026Phase 3

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

A phase 3 trial is testing KAI-9531, a once-weekly subcutaneous injection, versus semaglutide and placebo for weight loss in 1,200 people with obesity without diabetes. The 76-week randomized, partially-blinded study targets completion in March 2028 with percent body weight change as the primary endpoint. Kailera is positioning KAI-9531 as a direct competitor to Wegovy in the crowded obesity market, attempting to differentiate through superior weight loss efficacy. This represents another entrant challenging Novo Nordisk's established position in obesity treatment.

GLP-1Weight lossKaileraNovo Nordisk

Strategic Signal

Clinical Trial17 Jun 2026Phase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Phase 3 cardiovascular and kidney outcomes trial testing retatrutide in adults with BMI ≥27 kg/m² and atherosclerotic cardiovascular disease and/or chronic kidney disease. Enrollment targets 10,000 participants in a double-blind, placebo-controlled, event-driven design running approximately 5 years through February 2029. Eli Lilly advances retatrutide into major outcomes territory, competing directly with established GLP-1 agents that already hold cardiovascular indications like Wegovy and future tirzepatide expansions. This represents the largest cardiovascular outcomes program for any triple agonist to date.

CardiovascularKidneyWeight lossEli Lilly

Strategic Signal

Clinical Trial16 Jun 2026Phase 3

The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

Phase 3 trial evaluates semaglutide versus placebo in adults with non-cirrhotic NASH, measuring steatohepatitis resolution, fibrosis improvement, and cirrhosis-free survival over approximately 5 years. The study enrolled 1,205 adults and is active but not recruiting, with completion expected in 2029. This represents Novo Nordisk's push into NASH, a major unmet need with no approved GLP-1 therapies despite strong preclinical rationale. The trial's dual primary endpoints and 5-year duration suggest preparation for a pivotal regulatory filing in this large addressable market.

GLP-1Liver/NASHNovo Nordisk

Strategic Signal

Clinical Trial11 Jun 2026Phase 3

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

Strategic Signal

Clinical Trial11 Jun 2026Phase 3

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

Strategic Signal

Clinical Trial9 Jun 2026Phase 3

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

Phase 3 trial compares CagriSema (cagrilintide + semaglutide combination) 1.0 mg weekly versus tirzepatide 5 mg weekly in 1,023 adults with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor, or both. Active comparator design with 68-week duration, completion expected June 2026. This represents Novo Nordisk's direct challenge to Eli Lilly's tirzepatide dominance, testing whether dual amylin/GLP-1 combination can match dual GIP/GLP-1 efficacy in the core type 2 diabetes market. Head-to-head positioning against tirzepatide's lowest approved dose could support differentiated commercial messaging if CagriSema demonstrates superiority.

GLP-1Type 2 diabetesDrug comparisonsNovo NordiskEli Lilly
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