HR17031 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=401 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=393 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

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

Efficacy and safety benefits of HR17031, a fixed-ratio combination of INS068 and noiiglutide, versus its components alone in Chinese patients with type 2 diabetes uncontrolled on oral antidiabetic drug(s): A phase 2, multicentre, open-label, randomised, parallel three-arm, treat-to-target trial. (PubMed, Diabetes Obes Metab) - "HR17031 is effective and well-tolerated in patients with type 2 diabetes uncontrolled on metformin with or without a second oral antidiabetic drug."

Journal • P2 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=401 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial primary completion date: Mar 2025 ➔ Aug 2025

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

A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=401 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=393 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial • 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

A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed

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

A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites (clinicaltrials.gov) - P1 | N=24 | 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

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 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • 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

A Trial of HR17031 Injection With Renal Insufficiency (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Trial of HR17031 Injection With Hepatic Insufficiency (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial • Diabetes • Hepatitis C • Liver Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

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