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

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

Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. (PubMed, Clin Pharmacokinet) - P1, P2, P2/3 | "The final popPK model, incorporating significant covariates (baseline WT, baseline eGFR, Nab, STUDY, and ARM), provided robust and precise PK parameter estimates, confirming its applicability in both healthy subjects and those with T2D. The minimal and clinically insignificant impact of baseline WT and eGFR on drug exposure supports the conclusion that no dose adjustment is necessary based on these factors. Moreover, the higher absorption rate constant suggests a rapid onset of action, and the extended half-life supports less frequent dosing, potentially improving patient adherence."

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

Supaglutide alleviates hepatic steatosis in monkeys with spontaneous MASH. (PubMed, Diabetol Metab Syndr) - "Supaglutide exerts beneficial effects on hepatic and metabolic outcomes in spontaneous MASH monkeys."

Journal • Addiction (Opioid and Alcohol) • Diabetes • Fibrosis • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

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

New P2 trial • Genetic Disorders • Obesity

A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients(SUPER-1) (clinicaltrials.gov) - P2/3 | N=547 | Completed | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Active, not recruiting ➔ Completed

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

Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Aug 2023

Trial completion • Trial completion date

A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients On Metformin Treatment(SUPER-2) (clinicaltrials.gov) - P2/3 | N=620 | Completed | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Active, not recruiting ➔ Completed

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

A Single-Center, Open-Label, Fixed-Sequence Clinical Study to Evaluate the Pharmacokinetic Effects of Supaglutide on Digoxin or Metformin in Healthy Subjects (ADA 2024) - "Supaglutide injection can be used in combination with digoxin or metformin without dose adjustment."

Clinical • PK/PD data • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Efficacy and safety of supaglutide monotherapy in patients with type 2 diabetes (EASD 2023) - P2/3 | "Our data showed that supa improved glycemic and metabolic control and was well tolerated in T2D, suggesting supa as a novel alternative therapy for T2D and metabolic disorders."

Clinical • Monotherapy • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of supaglutide as add-on to metformin in patients with type 2 diabetes (EASD 2023) - P2/3 | "Supa 3 mg improved glycemic and metabolic control and was well tolerated in T2D inadequately controlled on metformin, suggesting supa as a novel alternative therapy for T2D and metabolic disorders."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of Supaglutide as Add-on to Metformin in Patients with Type 2 Diabetes (ADA 2023) - P2/3 | "The most common TEAEs with supa were GI symptoms, such as nausea, vomiting, diarrhea and decreased appetite mostly in mild or moderate severity. Supa 3 mg improved glycemic and metabolic control and was well tolerated in T2D inadequately controlled on metformin, suggesting supa as a novel alternative therapy for T2D and metabolic disorders."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of Supaglutide Monotherapy in Patients with Type 2 Diabetes (ADA 2023) - P2/3 | "The most common TEAEs with supa were GI symptoms, such as nausea, vomiting, diarrhea and decreased appetite, mostly in mild or moderate severity. Our data showed that supa improved glycemic and metabolic control and was well tolerated in T2D, suggesting supa as a novel alternative therapy for T2D and metabolic disorders."

Clinical • Monotherapy • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P1 trial

A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients On Metformin Treatment (clinicaltrials.gov) - P2/3 | N=620 | Active, not recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting | N=375 ➔ 620

Enrollment change • Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients (clinicaltrials.gov) - P2/3 | N=547 | Active, not recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting | N=324 ➔ 547

Enrollment change • Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus