The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Obesity

Treatments: Drug: placebo; Drug: SHR20004

Study type: Interventional

Funder types: Industry

Identifiers

NCT04799327

SHR20004-202

Details and patient eligibility

About

The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.

Enrollment: 254 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent obtained prior to any trial-related activities
2. Body mass index (BMI) between 28 and 40 kg/m2(both inclusive)
3. Diet and exercise management for at least 3 months before screening and less than 5% change in body weight during the previous 3 months（self-reported）.

Exclusion criteria

1. History of endocrine disease or treatment that may significantly affect body weight prior to screening visit
2. History of diabetes
3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
4. History of pancreatitis
5. Previous surgical treatment of obesity
6. Screening calcitonin of 20 ng/L or above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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254 participants in 4 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: SHR20004

Drug: SHR20004

Drug: SHR20004

Treatment group B

Experimental group

Treatment:

Drug: SHR20004

Drug: SHR20004

Drug: SHR20004

Treatment group C

Experimental group

Treatment:

Drug: SHR20004

Drug: SHR20004

Drug: SHR20004

Treatment group D

Placebo Comparator group

Treatment:

Drug: placebo