Diabegone (efsubaglutide alfa) / Innogen Pharmaceutical Technology - LARVOL DELTA

Long-acting management of diabetes and associated complications using an injectable thermosensitive hydrogel incorporating IgG-conjugated GLP-1RA. (PubMed, Theranostics) - "Herein, we developed a sustained-release hydrogel-based delivery system for Efsubaglutide Alfa (Suba), an IgG-conjugated GLP-1RA, designed to alleviate treatment burden and enhance patient adherence...Additionally, this system ameliorated diabetes-related complications by improving lipid metabolism, reversing hepatic steatosis and enhancing nerve fiber density. The Suba@T-gel system represents a promising strategy for long-acting management of diabetes and substantial improvement in patient compliance."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE） (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Metabolic Drug, Electrophysiological Savior: Unmasking GLP-1RA's Novel Therapeutic Target in Sinoatrial Node Dysfunction (AHA 2025) - "This study identifies Supaglutide as the first GLP-1RA capable of restoring SAN electrophysiology via oxidative and calcium signaling regulation, beyond glucose control. These findings not only uncover a novel function of GLP-1RA beyond metabolic regulation but also suggest that targeting SAN-specific mechanisms may represent a broader therapeutic strategy for arrhythmogenic cardiac diseases, especially those associated with metabolic disorders."

Late-breaking abstract • Cardiovascular • Diabetes • Fibrosis • Heart Failure • Immunology • Inflammation • Metabolic Disorders • CAMK2D • CD86 • RYR2 • SIRT3 • TNFA

Efficacy and safety of efsubaglutide alfa in individuals with type 2 diabetes (SUPER1): a randomised, double-blind, placebo-controlled, Phase IIb/III trial. (PubMed, Diabetologia) - P2/3 | "Efsubaglutide alfa significantly improved glycaemic management and promoted weight loss in drug-naive individuals with type 2 diabetes, with a favourable safety profile. These results establish efsubaglutide alfa as a promising therapeutic option for type 2 diabetes and related metabolic disorders."

Journal • P2/3 data • P2b data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Biweekly dosing of efsubaglutide alfa maintains glycaemic and continuous glucose monitoring control in type 2 diabetes: A randomised multicentre trial. (PubMed, Diabetes Obes Metab) - "Over 12 weeks, efsubaglutide alfa 3 mg Q2W provided glycaemic and CGM benefits comparable to 1 mg QW with favourable tolerability. These findings support the feasibility of a biweekly regimen as an alternative to weekly dosing; larger, longer-duration confirmatory trials in more diverse populations are warranted."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Mellitus. (PubMed, Clin Pharmacokinet) - P2/3 | "Efsubaglutide alfa demonstrates a strong E-R relationship for glycemic control and weight reduction in drug-naïve participants with T2DM. The extended half-life and favorable safety profile of efsubaglutide alfa make it well-suited for once weekly or biweekly monotherapy in patients with newly diagnosed T2DM."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Treated with Metformin. (PubMed, Clin Pharmacokinet) - P2/3 | "Efsubaglutide alfa, combined with metformin, significantly improves glycemic control and weight management, with an acceptable safety profile. This E-R model provides insights for dose optimization and trial design, and supports its use as an effective add-on therapy for patients with T2D, as indicated in the drug specification."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of Efsubaglutide Alfa in "overrun" patients in the SUPER2 trial: A post-hoc analysis for comprehensive evaluation. (PubMed, Diabetes Obes Metab) - "Efsubaglutide Alfa 1 mg provided clinically meaningful glucose lowering with good tolerability but without significant weight loss. These results support a lower-dose strategy for elderly or frail patients, those with low BMI, or individuals sensitive to gastrointestinal effects, and as a possible lead-in step before escalation. Confirmatory trials are warranted to establish long-term outcomes."

Journal • Retrospective data • Diabetes • Genetic Disorders • Geriatric Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients. (clinicaltrials.gov) - P2 | N=59 | Completed | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ May 2025

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Randomized Controlled Trial Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

New P4 trial • Genetic Disorders • Obesity

The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (ENLIGHT) (clinicaltrials.gov) - P2/3 | N=992 | Recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Phase classification: P2 ➔ P2/3 | N=200 ➔ 992 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Nov 2025 ➔ Aug 2026

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

BUSINESS UPDATE ON CLINICAL TRIAL OF CORE PRODUCT IN AUSTRALIA (HKEXnews) - "On 25 August 2025, the Company has completed the first patient dosing in its Phase II clinical trial of the Core Product for the treatment of obesity and being overweight in Australia. The Company expects approximately 200 participants to be enrolled for such clinical trial."

Trial status • Obesity

The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE） (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

A Follow-up Observational Study on the Discontinuation of Efsubaglutide Alfa in Individuals with Overweight or Obesity (GOAL-2) (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New trial • Genetic Disorders • Obesity

China's Innogen expects to complete weight-loss drug trials next year (Reuters) - "Chinese drugmaker Innogen expects to complete a late-stage clinical trial of its experimental weight-loss drug candidate next year, its CEO said on Tuesday, the latest Chinese company to join the race to develop obesity treatments....'I think the Phase IIB will be out by the end of this year, then Phase III will be (finished) by next year.'"

Trial completion date • Obesity • Type 2 Diabetes Mellitus

Effect of Efsubaglutide Alfa on the Pharmacokinetics of Metformin and Digoxin in Healthy Participants. (PubMed, Clin Pharmacokinet) - P1 | "No clinically significant pharmacokinetic change of digoxin and metformin was identified, and no new safety issues were observed with the co-administration of efsubaglutide alfa injection. These findings suggest that no dose adjustments are required for digoxin and metformin when co-administration with efsubaglutide alfa."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Diabetes Remission in Drug-Naïve Patients with Type 2 Diabetes (T2D) after Efsubaglutide Alfa Treatment (ADA 2025) - "Suba demonstrated efficacy in achieving stable glycemic control and drug-free diabetes remission. Enhanced β-cell function emerged as a key factor contributing to long-term remission."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Post Hoc Analysis of Efsubaglutide Alfa Monotherapy and Combined Therapy with Metformin in T2D Patients by Baseline Characteristics (ADA 2025) - "Significant reductions in HbA1c were achieved with Suba treatment, the monotherapy and the combined therapy, nevertheless their age, BMI, gender, and HbA1c."

Clinical • Monotherapy • Retrospective data • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Efsubaglutide Alfa in Patients with Obesity or Overweight—A Phase 2 Study (ADA 2025) - P2 | "Suba showed a favorable safety profile and significant weight loss in overweight/obese pts. Most pts achieved clinically meaningful weight loss target, indicating Suba's potential as an effective weight management option."

Clinical • P2 data • Diabetes • Metabolic Disorders • Obesity

Safety, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa in healthy participants: A randomised, dose-escalation phase 1 study. (PubMed, Diabetes Obes Metab) - "Efsubaglutide Alfa was well tolerated in healthy participants, with a favourable PK and PD profiles that support further clinical development in type 2 diabetes and metabolic disorders."

Journal • P1 data • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

A follow-up observational study on patients with obesity and overweight after discontinuing the injection of different doses of Efsubaglutide Alfa (GOAL-1) (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New trial • Genetic Disorders • Obesity

LIGHT: A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Efficacy and Safety of Efsubaglutide Alfa Injection 3 Mg Q2W in T2D Patients (clinicaltrials.gov) - P3 | N=88 | Not yet recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Multicenter, Randomized, Controlled Clinical Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients with Poor Glycemic Control After Diet and Exercise Intervention. (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus