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

ClinicalTrials11 Mar 2026·Phase 3● 6/10i

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: 2026-12-25 | Status: Active Not Recruiting | Last update: 2026-03-11

View original source ↗

Related signals

FDA1 Apr 2026·New Drug Approval (NDA/BLA)● 10/10iHigh impact

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

ClinicalTrials19 Mar 2026·Phase 3● 9/10iHigh impact

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

ClinicalTrials17 Apr 2026·Phase 3● 8/10iHigh impactPick of the week

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

ClinicalTrials17 Apr 2026·Phase 3● 8/10iHigh impact

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Phase 3 trial evaluating retatrutide for chronic low back pain in people with obesity or overweight, targeting dual primary endpoints of pain intensity reduction and weight loss. 586-person placebo-controlled study expected to complete September 2027, investigating a novel indication beyond traditional metabolic endpoints. Eli Lilly is exploring pain management as a potential expansion for their triple agonist, representing the first major trial of a GLP-1-based therapy specifically for chronic pain conditions.

GLP-1Weight lossOtherEli Lilly