Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

Clinical Trial30 Apr 2026Phase 3

Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

Novo Nordisk A/S

Phase 3 randomized controlled trial evaluating semaglutide versus placebo for diabetic retinopathy progression in adults with type 2 diabetes. The 5-year study targets 1,500 participants and measures 3-step Early Treatment Diabetic Retinopathy Study progression as primary endpoint. Novo Nordisk is testing whether their established GLP-1 can expand beyond diabetes and weight management into ophthalmology, potentially opening a new indication where no GLP-1 currently holds approval. This represents one of the longest-duration ophthalmology studies in the metabolic space.

Strategic Signal

Novo is pursuing diabetic retinopathy as a third major indication for semaglutide after diabetes and obesity approvals. The 5-year endpoint creates a lengthy development timeline that could delay market entry until 2027-2028, giving competitors time to establish positions in diabetic complications. This mirrors Novo's broader strategy of expanding semaglutide across multiple conditions to maximize patent life and differentiate from Eli Lilly's tirzepatide in core metabolic markets.

GLP-1Type 2 diabetesNovo Nordisk

Original Abstract

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years. | Condition(s): Diabetes Mellitus, Type 2 | Primary endpoint(s): Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression. | Enrollment: 1,500 (estimated) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2027-11-07 | Status: Active Not Recruiting | Last update: 2026-04-30

View original source ↗

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 Lilly Novo 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)

Phase 3 SURMOUNT-1 tests once-weekly tirzepatide at three doses versus placebo in adults without type 2 diabetes who have obesity or are overweight with comorbidities. The randomized, double-blind trial targets 2,539 participants with primary efficacy assessment at 72 weeks. This represents tirzepatide's pivotal obesity trial against placebo, potentially supporting Eli Lilly's bid to compete directly with Wegovy in the non-diabetic obesity market. A prediabetes subgroup continues long-term to assess diabetes prevention.

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