Overview of Phase 3 Clinical Trials for GLP-1-Based Anti-Obesity Drug Candidates in China

May 11, 2024 15:45 CST Updated 15:46

Novo Nordisk

Insulin Developer and Manufacturer

Eli Lilly

Global Pharmaceutical R&D and Production Company

Innovent

High-end Biologics Developer

Hengrui Pharma

Innovative and High-Quality Pharmaceutical Developer

Sciwind

Metabolic Disease Drug Developer

CSPC

Developer of finished drugs and active pharmaceutical ingredients

Boehringer Ingelheim

Developer of Innovative Drugs and Therapies

Zealand Pharma

Innovative Drug Developer

▎Edited by the WuXi AppTec content team

Today (May 11) is"World Obesity Prevention Day"。

According to the data from the World Obesity Day official website,By 2035, it is estimated that there will be 1.9 billion obese people worldwide, with one in four individuals suffering from obesity. Between 2020 and 2035, childhood obesity is projected to increase by 100%.Overweight/obesity increases the risk of developing various chronic diseases such as hypertension, type 2 diabetes, and cardiovascular and cerebrovascular diseases, and has become a serious public health issue affecting people's health.

Obesity drugs have now become one of the important directions in the field of new drug research and development. Among them,Glucagon-like peptide-1 (GLP-1) receptor agonists have become the focus in the field of obesity drug development due to their excellent clinical data and efficacy.。InIn January this year, the globally renowned technology media "MIT Technology Review" (MIT Technology Review) published in the 2024 "Top 10 Breakthrough Technologies" globally,GLP-1 Receptor Agonist Weight Loss Therapy Successfully Makes the List。

According to the China Drug Clinical Trial Registration and Information Disclosure Platform,ClinicaltrialsWebsite Information，Currently, there are also severalGLP-1 as the targetThe new drug is being developed in China forObese and Overweight PopulationPhase 3 Clinical StudyThis article will introduce these drugs based on publicly available information for readers' reference only (the order is not significant).

Image Source: 123RF

Novo Nordisk: Semaglutide Injection/Semaglutide Tablets、CagriSema
Mechanism of Action:GLP-1 Receptor Agonist,Long-Acting Combination Therapy

Semaglutide isDeveloped by Novo NordiskA GLP-1 receptor agonist.June 2023,The Center for Drug Evaluation (CDE) of the China National Medical Products Administration has acceptedSemaglutide InjectionIndication for weight loss in the marketing application.Novo Nordisk is conducting an international multicenter trial (including China) Phase 3 clinical study (STEP 12) in China, aiming toIn overweight and obese adult subjectsEvaluate the efficacy and safety of once-weekly semaglutide injection 2.4mg.

Semaglutide TabletsYesDeveloped by Novo NordiskOralGLP-1 Receptor Agonist, Already in ChinaApprovedFor the treatment of adult type 2 diabetes.Novo Nordisk is conducting a Phase 3 clinical study (OASIS 3) in China, comparingSemaglutide Tablets 50mg Once DailyEfficacy and Safety as an Adjunct to Caloric Restriction and Increased Physical Activity in Chinese Adults with Overweight or Obesity.

CagriSema is a long-acting fixed-dose combination therapy in development by Novo Nordisk, consisting ofLong-acting Amylin AnaloguescagrilintideAndGLP-1RA SemaglutideComposition. Amylin, apart from the GLP-1 signaling pathway, is another hormone related to hunger and satiety. It is co-secreted with insulin to play a role in glucose regulation.Novo Nordisk has launched an observational study in China to explore how CagriSema can helpOverweight Population in ChinaPhase 3 Study of Weight Loss。

Eli Lilly: Tirzepatide Injection,LY3502970 Capsules
Mechanism of Action:GIP/GLP-1 Dual Receptor Agonist,GLP-1 Receptor Small Molecule Agonist

Tirzepatide Injection（tirzepatide）Developed by Eli Lilly and CompanyA once-weekly injection of glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonistIn August 2023, Eli Lilly had already been in China.SubmissionLETirzepatideUsed forLong-term Weight Management in AdultsMarketing Application for Indications.

Eli Lilly is conducting three international multicenter (including China) Phase 3 clinical trials in China, respectively: 1) Evaluating the once-weekly administration of tirzepatide.Non-Type 2 Diabetes Patients with Obesity or Overweight Related to Weight-Associated ComorbiditiesThe efficacy and safety in; 2) Evaluate the once-weekly administration of Tirzepatide for treatmentObstructive Sleep Apnea and ObesityEfficacy and Safety of Subjects (SURMOUNT-OSA); 3) Evaluation of Tirzepatide inReduction of Comorbidities and Mortality in Adult ObesityResearch on the Role in Terms of...

Orforglipron (LY3502970 Capsule)Developed by Eli Lilly, a once-dailyOral, Non-Peptide GLP-1 Receptor Small Molecule Agonist. One advantage of this drug isIt is a non-peptide molecule., making it easier to manufacture and package into tablets. Eli Lilly has launched an international multicenter (including China) Phase 3 clinical trial (ATTAIN-1 study) to evaluate the efficacy and safety of once-daily oral orforglipron capsules compared to placebo in subjects with obesity or overweight with weight-related comorbidities.

Image Source: 123RF

Innovent Bio: Masitopeptide

Mechanism of Action: GLP-1R/GCGR Dual Agonist

Mashiduo Peptide (IBI362) is a GLP-1R/GCGR dual agonist under research by Innovent Bio. In February this year,The first new drug marketing application for MASH peptide has been accepted by the CDE.Acceptance, for use inLong-term Weight Control in Adult Patients with Obesity or Overweight。

Innovent Bio is conducting in ChinaTwo itemsPhase 3 Clinical Study of Masidepeptide, respectively:1) The GLORY-1 study is being evaluated in Chinese overweight or obese subjects.Mashiduo Peptide2mg、4mg、6mgEfficacy and Safety;2) The GLORY-2 study is being evaluated in Chinese obese subjects.Mashiduo Peptide9 mgEfficacy and safety.Among them, the GLORY-1 study has already achieved its primary endpoint and all key secondary endpoints in January 2024.Trial data show that subjects in the 4mg and 6mg groups of MASH peptideImprovements in body weight and multiple cardiometabolic indicators were significantly superior to the placebo group.。

Hengrui Pharma: HRS9531
Mechanism of Action:GLP-1/GIP Dual Receptor Agonist

HRS9531 Injection is developed by Hengrui Pharma.A Novel GLP-1/GIP Dual Receptor AgonistIn May this year, Hengrui Pharma has initiated a multi-center, randomized, double-blind, placebo-controlled parallel Phase 3 clinical study in China.In overweight or obese subjectsEvaluate the Efficacy and Safety of HRS9531 Injection. The primary objective of the trial is to assess the efficacy of HRS9531 Injection in reducing body weight in overweight or obese subjects compared to placebo after 48 weeks of treatment.

Sciwind: Enotuglipin Injection

Mechanism of Action:GLP-1 Receptor Agonist

Ecnoglutide (XW003, ecnoglutide) is a long-acting GLP-1 receptor agonist with cAMP bias developed by Sciwind. It is currently under development for the treatment of type 2 diabetes and obesity indications.Sciwind is currently conducting aEli Lilly's GLP-1 receptor agonistInjection solution inAdult Overweight or Obese SubjectsA multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial (SLIMMER) in China. Meanwhile,Sciwind is also developingOral administration of Enotegrapin tablets.It is worth mentioning that, on May 7,Sciwind Biosciences JustAnnouncementThe development and commercialization rights of Enotuglutide Injection in South Korea have been licensed toHK inno.N Corporation, the upfront payment for this collaboration is up to 56 million US dollars.。

CSPC: TG103
Mechanism of Action:GLP-1 Receptor Agonist

TG103 is a GLP-1 receptor agonist developed by CSPC Pharmaceutical Group. According to the company's press release, the drug has been approved to conduct clinical trials for multiple indications, including type 2 diabetes, overweight/obesity, non-alcoholic steatohepatitis (NASH), Alzheimer’s disease, and others. It has completed phase 2 clinical trials for the treatment of type 2 diabetes and overweight/obesity indications. According to the Clinicaltrials website, CSPC has registered a multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate TG103 injection for...Non-diabetic overweight or obese subjectsThe efficacy, safety, pharmacokinetic characteristics, and immunogenicity.

Boehringer Ingelheim/Zealand Pharma：survodutide

Mechanism of Action: GCGR/GLP-1R Dual Agonist

Survodutide (BI 456906) is jointly developed by Boehringer Ingelheim and Zealand Pharma.GLP-1 receptor and glucagon (GCG) receptor dual agonist`, the product`Can suppress appetite while increasing energy expenditure, thereby treating obesity.

Boehringer Ingelheim is conducting several international multicenter (including China) Phase 3 clinical trials in China, two of which are...Overweight or obese subjects without type 2 diabetes、Subjects who are overweight or obese and have type 2 diabetesComparison of Survodutide in ChinaSubcutaneous AdministrationA 76-Week Study on the Efficacy and Safety of Placebo Administration。In addition, Boehringer Ingelheim is also evaluating BI 456906 forImpact on Cardiovascular Safety in Overweight or Obese PopulationsResearch, as well as for overweight or obese individuals with at least one weight-related complicationChinese SubjectsClinical Research.

Image Source: 123RF

In addition to the aforementioned products, several other new weight-loss drugs are undergoing various types of clinical research in China. Due to space limitations, they will not be individually introduced here.It is hoped that these weight-loss drugs under research can continue to make new breakthroughs in subsequent development, obtain approval for marketing as soon as possible, and benefit a large number of patients!

References:
[1] World Obesity Day Official Website. From https://www.worldobesityday.org/

[2] Official Website of China Drug Clinical Trial Registry and Information Disclosure Platform. Retrieved May 11, 2024,from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml
[3] ClinicalTrials website, from https://www.clinicaltrials.gov/

[4] Official websites and press releases of various companies

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