A 26-Week,Randomised,Open-Label,Multicenter,Active-Controlled,Parallel-Design,Phase III Clinical Trial to Compare the Efficacy and Safety of Insulin Degludec/Liraglutide Injection With XULTOPHY® Once Daily Via Subcutaneous Injection in Chinese Subjects With Type 2 Diabetes

ClinicalTrials19 Aug 2024·Phase 3● 5/10i

A 26-Week,Randomised,Open-Label,Multicenter,Active-Controlled,Parallel-Design,Phase III Clinical Trial to Compare the Efficacy and Safety of Insulin Degludec/Liraglutide Injection With XULTOPHY® Once Daily Via Subcutaneous Injection in Chinese Subjects With Type 2 Diabetes

Tonghua Dongbao Pharmaceutical Co.,Ltd

Phase 3 trial compares Chinese-manufactured insulin degludec/liraglutide combination to Novo Nordisk's Xultophy in adults with type 2 diabetes. Open-label study targets 510 participants over 26 weeks with HbA1c reduction as primary endpoint, expected completion October 2025. Tonghua Dongbao tests its biosimilar combination against the established Novo Nordisk product in the Chinese market. This represents China's push toward domestic alternatives in the GLP-1/insulin combination space.

Strategic signal

Chinese biosimilar manufacturers are targeting high-value combination therapies like GLP-1/insulin products to capture domestic market share. Successful approval of Tonghua Dongbao's combination could pressure Novo's Xultophy pricing in China and establish precedent for complex biosimilar approvals in Asia's largest diabetes market. This mirrors the SGLT2 biosimilar wave that reshaped diabetes treatment costs across emerging markets in 2022-2024.

GLP-1Type 2 diabetesDrug comparisonsTonghua Dongbao Pharmaceutical Co.,Ltd Novo Nordisk

Original Abstract

This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes. | Condition(s): Type 2 Diabetes | Primary endpoint(s): Change from baseline in HbA1c after 26 weeks of treatment | Enrollment: 510 (estimated) | Phase: Phase 3 | Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd | Expected completion: 2025-10 | Status: Not Yet Recruiting | Last update: 2024-08-19

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