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PubMed1 Apr 2026Diabetes, obesity & metabolism● 6/10i

GLP-1 receptor agonists and cardiovascular outcomes in Asian, Black or African American, and White populations: An updated meta-analysis including the SOUL trial.

Hasebe M, Su CY, Kamido H, Yabe D, Yoshiji S

GLP-1 receptor agonists reduced cardiovascular risk by 27% in Asian populations versus 14% in White populations, with similar but non-significant effects in Black or African American populations. Meta-analysis of 9 trials including 74,703 participants with type 2 diabetes or overweight/obesity. This provides the first robust evidence of differential GLP-1RA cardiovascular benefits across racial groups, with Asian populations showing significantly greater relative risk reduction. The finding emerges from inclusion of the recent SOUL trial data.

Strategic Signal

FDA will face pressure to include race-specific efficacy data in GLP-1RA labels, following precedents set by BiDil for heart failure and recent FDA guidance on diverse clinical trial enrollment. Novo Nordisk and Eli Lilly can leverage the stronger Asian efficacy data for market access in Japan and other Asian markets where HTA bodies increasingly demand population-specific evidence. The non-significant result in Black populations, despite similar point estimates, creates a medical affairs challenge requiring careful KOL education to avoid misinterpretation of statistical versus clinical significance.

GLP-1CardiovascularNovo NordiskEli Lilly

Original Abstract

AIMS: To evaluate the cardiovascular efficacy of glucagon-like peptide-1 receptor agonists (GLP-1RAs) in Asian, Black or African American, and White populations, and to assess whether the magnitude of cardiovascular risk reduction differs across these populations. MATERIALS AND METHODS: PubMed and EMBASE were searched to 11 November 2025 for randomized placebo-controlled GLP-1RA trials in adults with type 2 diabetes or overweight/obesity that reported race-stratified major adverse cardiovascular events (MACE; cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke). Hazard ratios (HRs) for MACE were extracted for Asian, Black or African American, and White populations. Random-effects meta-analyses were used to obtain pooled HRs and ratios of HRs (RHRs) comparing treatment effects between populations. RESULTS: Nine trials, including the recent SOUL trial, were included, comprising 8164 Asian, 4036 Black or African American, and 62 503 White participants. GLP-1RAs reduced MACE risk in Asian (HR 0.73; 95% CI 0.63-0.85; p < 0.001) and White populations (HR 0.86; 95% CI 0.81-0.91; p < 0.001). In Black or African American populations, the effect was similar to that in White populations (HR 0.88; 95% CI 0.67-1.15; p = 0.34) but did not reach statistical significance. The pooled RHR for Asian versus White populations was 0.84 (95% CI 0.71-0.98; p = 0.027), indicating a significantly greater risk reduction in Asian populations. The RHR for Asian versus Black or African American populations was 0.81 (95% CI 0.57-1.16; p = 0.25), with point estimates favouring Asian populations. CONCLUSIONS: GLP-1RAs reduced MACE risk across populations, with greater relative risk reduction in Asian populations and broadly similar benefits in Black or African American and White populations.

Related signals

Strategic Signal

FDA1 Apr 2026New Drug Approval (NDA/BLA)High impact● 10/10i

FDA Approves Foundayo (Orforglipron) — New Drug Approval (NDA/BLA)

FDA approved orforglipron (Foundayo, Eli Lilly) for type 2 diabetes -- a once-daily oral small-molecule GLP-1 receptor agonist. Orforglipron is the first non-peptide oral GLP-1 approved in the US; oral semaglutide (Rybelsus, Novo Nordisk) has been approved for T2D since 2019 and expanded to obesity in January 2026. Unlike Rybelsus, orforglipron requires no fasting or water volume restrictions before dosing.

GLP-1Type 2 diabetesPricing/accessEli LillyNovo Nordisk

Strategic Signal

Clinical Trial19 Mar 2026Phase 3High impact● 9/10i

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

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Weight lossGLP-1Eli Lilly

Strategic Signal

Clinical Trial17 Apr 2026Phase 3High impact● 8/10i

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Phase 3 open-label trial compared once-daily oral orforglipron versus insulin glargine in people with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study enrolled 2,749 participants with primary endpoint of time to first major adverse cardiovascular event, completed in March 2026. Eli Lilly is positioning orforglipron as a cardiovascular outcomes option in high-risk populations, directly competing with established insulin therapy in this indication. This represents the first cardiovascular outcomes trial for orforglipron following its April 2026 FDA approval for type 2 diabetes.

GLP-1Type 2 diabetesWeight lossCardiovascularEli Lilly

Strategic Signal

Clinical Trial13 Apr 2026Phase 3High impact● 8/10i

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity

Eli Lilly is conducting a Phase 3 head-to-head trial comparing retatrutide versus tirzepatide in adults with obesity. The double-blind study targets 800 participants over 89 weeks with primary endpoint of percent body weight change, completing December 2026. This represents the first direct comparison between Eli Lilly's next-generation triple receptor agonist retatrutide and its approved dual agonist tirzepatide in obesity. The trial positions Eli Lilly to potentially establish superiority claims for retatrutide ahead of expected regulatory submissions.

GLP-1Weight lossDrug comparisonsEli Lilly

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