noiiglutide (SHR20004) / Jiangsu Hengrui Pharma - LARVOL DELTA

Pharmacokinetics and safety of HR17031, a fixed-ratio of INS068/Noiiglutide combination, in Chinese patients with hepatic impairment. (PubMed, Diabetes Obes Metab) - "HR17031 demonstrated PK profiles of INS068 and Noiiglutide comparable between subjects with mild or moderate hepatic impairment and those with normal hepatic function, with modest reductions in moderate impairment. The treatment was well tolerated with a favourable safety profile, and no significant differences in C-peptide concentrations were observed across groups."

Journal • PK/PD data • Hepatology

Safety, pharmacokinetics and pharmacodynamics of multiple-dose noiiglutide (SHR20004), a novel GLP-1 receptor agonist, in Chinese obese subjects without diabetes mellitus. (PubMed, Diabetes Obes Metab) - "Daily administration of noiiglutide using a titration method was well tolerated by Chinese obese participants without DM and showed potential therapeutic effect for weight loss."

Journal • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

Benefits of HR17031, a Fixed-Ratio Combination of INS068 and SHR20004, vs. Its Components Alone in Patients (pts) with Type 2 Diabetes (T2D) Uncontrolled on Oral Antidiabetic Drug(s) (OADs) (ADA 2024) - "This trial assessed efficacy and safety of HR17031 vs INS068 and SHR20004 in pts with T2D. In this randomized phase 2 trial, 455 Chinese adults with T2D (HbA1c 7.5%-11.0%; previous metformin±another OAD) were randomized (2:2:1) to daily injections of HR17031 (n = 183), INS068 (n = 182) or SHR20004 (0.12 mg/d; n = 90). HR17031 is effective and well-tolerated in pts with T2D uncontrolled on OAD(s)."

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

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of noiiglutide injection on body weight in obese Chinese adults without diabetes: A multicentre, randomized, double-blind, placebo-controlled, phase 2 trial. (PubMed, Diabetes Obes Metab) - "In obese Chinese adults without diabetes, once-daily subcutaneous noiiglutide significantly reduced body week at week 24 compared with placebo, and had a manageable safety profile, primarily involving gastrointestinal disorders."

Clinical • Journal • P2 data • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Obesity

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=455 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects. (clinicaltrials.gov) - P2 | N=128 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Unknown status ➔ Completed

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

Pharmacokinetics of HR17031 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=450 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes (clinicaltrials.gov) - P2 | N=254 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes (clinicaltrials.gov) - P2; N=252; Enrolling by invitation; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Recruiting ➔ Enrolling by invitation

Clinical • Enrollment status • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Pharmacokinetics of HR17031 Injection in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Active, not recruiting

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

Pharmacokinetics of HR17031 Injection in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes (clinicaltrials.gov) - P2; N=252; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes (clinicaltrials.gov) - P2; N=252; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity