Clinical trials: sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.
- Trial name
- NCT06994650
- Testing
- HRS9531
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Overweight or Obesity
A Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
This study aims to evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.
- Trial name
- NCT05881837
- Testing
- HRS9531 injection
- Where
- 25 sites in China
- Volunteers
- 249 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Acute Ischemic Stroke
HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.
This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.
- Trial name
- NCT07233070
- Testing
- HRS-7450 Injection
- Where
- 2 sites in China
- Volunteers
- 210 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Hyperlipidemia
A Extension Study to Evaluate the Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
This is a Phase II multi-center, open-label extension (OLE) clinical trial of HRS-7249, a GalNAc-conjugated APOC3-targeted siRNA injection, enrolling two cohorts of participants.
- Trial name
- NCT07799688
- Testing
- HRS-7249 Injection
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Type 2 Diabetes
A Study of HRS-4729 Injection in Participants With Type 2 Diabetes
The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of…
- Trial name
- NCT07843862
- Testing
- HRS-4729 Injection, Mazdutide
- Where
- 2 sites in China
- Volunteers
- 240 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Overweight and Obesity
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
- Trial name
- NCT07559136
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Psoriasis Vulgaris
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
- Trial name
- NCT07802964
- Testing
- HRS-4139 Tablet
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Weight Management, Type 2 Diabetes
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese…
- Trial name
- NCT07841860
- Testing
- HRS-1596
- Where
- China
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Reversal of Neuromuscular Blockade
A Single Ascending Dose of HRS-2162 in Healthy Subjects
The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
- Trial name
- NCT07195604
- Testing
- HRS-2162
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH)
A Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment
This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8…
- Conditions
- Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), Type 2 Diabetes Mellitus
- Trial name
- NCT07807059
- Testing
- HRS-4729
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Fluid Retention Caused by Heart Failure
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention
- Trial name
- NCT07318103
- Testing
- HRS-9057 injection set, 5% Glucose Injection or 0.9% sodium chloride injection
- Where
- China
- Volunteers
- 153 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Fluid Retention Due to Heart Failure
A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up
- Trial name
- NCT07681479
- Testing
- [14C]HRS-9057
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Patients With Candidemia and/or Invasive Candidiasis
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
- Trial name
- NCT06194201
- Testing
- HRS9432, Caspofungin Acetate for Injection
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis
Phase II clinical trial evaluating the efficacy and safety of HRS-7249 and SHR-1918 in patients with severe hypertriglyceridemia at high risk of acute pancreatitis
- Trial name
- NCT07308392
- Testing
- HRS-7249 injection set, SHR-1918 injection set
- Where
- China
- Volunteers
- 119 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Atherosclerotic Cardiovascular Disease
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease.
- Trial name
- NCT07551492
- Testing
- HRS9531
- Where
- China
- Volunteers
- 9,262 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis
The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.
- Trial name
- NCT07660848
- Testing
- HRS-4729 Injection, HRS9531 Injection
- Where
- 2 sites in China
- Volunteers
- 160 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Prevention of Postoperative Nausea and Vomiting
A Clinical Trial of HRS5580 for Injection Combined With Palonosetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting
The study is being conducted to evaluate the efficacy of HRS5580 for injection combined with palonosetron hydrochloride in the prevention of postoperative nausea and vomiting, and to explore the effective dose of HRS5580 for…
- Trial name
- NCT07709897
- Testing
- HRS5580 for injection combined with palonosetron hydrochloride;, HRS5580 for injection combined with palonosetron hydrochloride, HRS5580 for injection blank preparation combined with palonosetron hydrochloride
- Where
- 2 sites in China
- Volunteers
- 260 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Subjects With Mild Hypertension
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-9563 in Subjects With Mild Hypertension: a Randomized, Double-blind, Placebo-controlled Phase I Study.
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
- Trial name
- NCT07117474
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Chronic Management of Body Weight
A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
- Trial name
- NCT07670884
- Testing
- HRS9531 Tablet
- Where
- 2 sites in China
- Volunteers
- 675 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Mild to Moderate Hypertension
Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension
This study aims to evaluate the efficacy and safety of HRS-9563 in patients with mild to moderate hypertension, and to explore its appropriate dosage.
- Trial name
- NCT07297797
- Testing
- HRS-9563 Injection, sodium chloride injection
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.