SHR-3167 / Jiangsu Hengrui Pharma - LARVOL DELTA

Once-weekly insulin SHR-3167 versus once-daily insulin glargine U100 in type 2 diabetes without previous insulin treatment (EASD 2026) - P2 | "Materials and Insulin-naive T2D patients (a diagnosis of T2D for ≥6 months prior to screening; HbA1c 7.5%-10.0%; previous metformin ± sodium-glucose cotransporter 2 inhibitor at stable dose for ≥3 months) were randomly assigned in a ratio of 1:1:1 to once- weekly SHR-3167 Group A (starting dose, 7 mg/week; ±2 mg/week), once-weekly SHR-3167 Group B (starting dose, 7 mg/week; ±1.5 mg/week), or once-daily IGlar (starting dose, 10 U/day; ±3 U/day). In adults with T2D who had not previously received insulin, once-weekly SHR-3167 achieved excellent glycemic control similar to IGlar, with no concerning hypoglycemia or other safety findings."

Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of once-weekly insulin SHR-3167 vs daily insulin degludec in type 2 diabetes participants previously treated with basal insulin with or without oral antidiabetic drugs (EASD 2026) - P2 | "Once-weekly insulin SHR-3167 showed numerically greater HbA1c reduction and clinically meaningful improvements in TIR, with a similar overall safety and hypoglycemia profile to that of once-daily insulin IDeg, in insulin-treated participants with T2DM."

Clinical • Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

SHR-3167-201: Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects (clinicaltrials.gov) - P2 | N=275 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Titration in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

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

To Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability Between SHR-3167 Injection and Glargine Insulin in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial

A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Titration in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

SHR-3167-201: Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects (clinicaltrials.gov) - P2 | N=275 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Nov 2025 ➔ Mar 2026

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

A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs (clinicaltrials.gov) - P2 | N=173 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

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

A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety of multiple-dose SHR-3167 injection in type 2 diabetic subjects at steady state. (ChiCTR) - P1 | N=50 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; Jiangsu Hengrui Medicine Co., Ltd.

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

A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=55 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Once-Weekly Insulin SHR-3167 in Healthy Subjects and Type 2 Diabetes Mellitus Participants—A Phase 1, Randomized, Single- and Multiple-Ascending Dose Study (ADA 2025) - "Once-weekly insulin SHR-3167 showed good tolerability, favorable pharmacokinetics, and evident glucose-lowering effects."

Clinical • P1 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-Weekly Insulin SHR-3167 vs. Insulin Glargine U100 (IGlar U100) in Healthy Subjects (ADA 2025) - "The PD/PK profiles, and safety of SHR-3167 support its potential as once-weekly regimen for glycemic management."

Clinical • Hypoglycemia • Metabolic Disorders

A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs (clinicaltrials.gov) - P2 | N=153 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

SHR-3167-201: Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects (clinicaltrials.gov) - P2 | N=273 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects (clinicaltrials.gov) - P2 | N=273 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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