ALDERIA INTELLIGENCE

A live view of the cardiometabolic category.

Research, clinical trials, and regulatory decisions curated daily for pharma executives and healthcare investors.

Try for free
12+Markets tracked
DailySignal updates
GLP-1 · SGLT2 · PCSK9Core coverage

Recent signals

View all →

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 Trial19 Oct 2026Phase 3

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Phase 3 head-to-head trial compares CagriSema (dual cagrilintide and semaglutide) 2.4/2.4 mg against tirzepatide 15 mg weekly in adults with type 2 diabetes inadequately controlled on metformin with or without SGLT2 inhibitors. The randomized trial enrolled 1,000 participants with primary endpoints of HbA1c and weight change, completing in March 2026. This represents Novo Nordisk's direct challenge to Eli Lilly's tirzepatide dominance with a novel dual-agonist combination targeting both GLP-1 and amylin receptors. The head-to-head design positions CagriSema for potential differentiation in the competitive dual-agonist space.

GLP-1Type 2 diabetesDrug comparisonsNovo NordiskEli Lilly

Strategic Signal

Clinical Trial19 Oct 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

Strategic Signal

Clinical Trial15 Oct 2026Phase 3

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin and/or Sulfonylureas in Patients With Type 2 Diabetes

BGM0504, a once-weekly injection from BrightGene Bio-Medical, is being tested against semaglutide as add-on therapy to metformin and/or sulfonylureas in adults with type 2 diabetes. The open-label phase 3 trial enrolls 537 participants in China with expected completion in March 2026. This represents a direct challenge to Novo Nordisk's Ozempic franchise in the Chinese market from a domestic biosimilar competitor. The head-to-head design against branded semaglutide signals BrightGene's confidence in demonstrating non-inferiority for regulatory approval and market access positioning.

GLP-1Type 2 diabetesDrug comparisonsBrightGene Bio-Medical Technology Co., Ltd.Novo Nordisk

Strategic Signal

Clinical Trial14 Oct 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 Trial13 Oct 2026Phase 3

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

RO7795068, a dual GLP-1/GIP receptor agonist from Roche, is being tested versus placebo for weight management in people with obesity or overweight and type 2 diabetes. Phase 3 trial targets 1,600 participants over 72 weeks in a randomized, double-blind, placebo-controlled design. This positions Roche to compete directly with Eli Lilly's tirzepatide (Mounjaro/Zepbound) in the dual incretin mechanism space across both diabetes and obesity indications. The trial represents Roche's first major entry into the competitive GLP-1 obesity market dominated by Novo Nordisk and Eli Lilly.

GLP-1Weight lossType 2 diabetesDrug comparisonsHoffmann-La RocheEli Lilly

Strategic Signal

Clinical Trial13 Oct 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
Questions? Book a consultation →