Clinical trials: sponsored by Gan & Lee Pharmaceuticals.
Hypoalbuminemia in Cirrhotic Ascites
A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of GLR1075 Injection in Healthy Trial Participants and Cirrhotic Trial Participants With Ascites and Hypoalbuminemia
This trial is conducted in China. This study plans to include 3 parts,Part A, a single ascending dose (SAD) study in healthy trial participants; Part B, a multiple dose (MD) study in healthy trial participants; and Part C, a…
- Trial name
- NCT07851688
- Testing
- Human Serum Albumin(HSA), GLR1075 Injection
- Where
- China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Healthy Subjects;Overweight or Obesity
A Phase 1 Study of GZC8072 Tablets Following a Single Dose in Healthy Study Participants and Multiple Doses in Obese/Overweight Study Participants
This trial is conducted in China. This study plans to include 2 parts, i.e., a single-dose study and a multiple-dose study: The single-dose study will be conducted in healthy adult participants to evaluate the safety…
- Trial name
- NCT07784699
- Testing
- GZC8072 Tablets
- Where
- China
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Type 2 Diabetes (T2DM)
Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes
Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.
- Trial name
- NCT07527078
- Testing
- GZR33 Injection, Insulin Degludec Injection (Tresiba®)
- Where
- China
- Volunteers
- 350 people
- Sponsor
- Gan & Lee Pharmaceuticals.
T2D
Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
- Trial name
- NCT07670897
- Testing
- GZR4 injection A, GZR4 injection B
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Type 2 Diabetes (T2DM)
Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes
This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.
- Trial name
- NCT07387003
- Testing
- GZR101-80, GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)
- Where
- China
- Volunteers
- 345 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Obstructive Sleep Apnea (OSA)
Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy
The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe…
- Trial name
- NCT07501832
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Obstructive Sleep Apnea (OSA)
Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea…
- Trial name
- NCT07493057
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Prostate Cancer
A Phase I Clinical Study of GLR2037 in Patients With Advanced Prostate Cancer
A Phase I Clinical Study of GLR2037 in Patients with Advanced Prostate Cancer
- Trial name
- NCT07468396
- Testing
- GLR2037
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Overweight or Obesity
Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss
This is a Phase 3 extension study conducted in subjects who have received GZR18 Injection once every 2 weeks (Q2W) for weight loss treatment for 52 weeks, aiming to explore the effect and safety of continuous injection of GZR18…
- Trial name
- GZR18-BWM-303 (NCT07292441)
- Testing
- GZR18 injection
- Where
- 2 sites in China
- Volunteers
- 500 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Obesity&T2D
Bioequivalence Study of GZR18 Injection Before and After CMC Change
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
- Trial name
- NCT07355738
- Testing
- GZR18 injection A, GZR18 injection B
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Biosimilarity
A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects
This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects. It is planned to enroll 198 male subjects in this study.
- Trial name
- NCT07334496
- Testing
- GLR1044 injection, Dupilumab Injection
- Where
- China
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Obesity or Overweight
Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral…
- Trial name
- NCT07128888
- Testing
- GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Diabetes
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)
This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2…
- Trial name
- NCT06767735
- Testing
- GZR4, Insulin Glargine U100
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Diabetes
Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment
This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.
- Trial name
- NCT07193147
- Testing
- GZR4
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Type 2 Diabetes Mellitus (T2DM)
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise
- Trial name
- Optimum 1 (NCT06777238)
- Testing
- GZR18
- Where
- China
- Volunteers
- 274 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Obesity/Overweight
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.
- Trial name
- NCT06728124
- Testing
- GZR18
- Where
- China
- Volunteers
- 630 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Obesity/Overweight in Adult
Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects
This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate…
- Trial name
- NCT07150975
- Testing
- GZR18, Semaglutide(Wegovy® )
- Where
- China
- Volunteers
- 420 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Diabetes
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial Insulin
This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 in Combination with Insulin Aspart (with or without Non-Insulin Antidiabetic…
- Trial name
- NCT06767761
- Testing
- GZR4, Insulin Glargine U100 group
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Type 2 Diabetes Mellitus (T2DM)
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with…
- Trial name
- Optimum 2 (NCT06778967)
- Testing
- GZR18, semaglutide
- Where
- China
- Volunteers
- 1,100 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Diabetes
A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with…
- Trial name
- NCT07165223
- Testing
- GZR4, Insulin Icodec group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Gan & Lee Pharmaceuticals.