A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

Sciwind Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Overweight and/or Obesity; Weight Management

Treatments: Drug: placebo with matching dosage; Drug: ecnoglutide tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07243171

SCW0503-1012

Details and patient eligibility

About

The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity

Full description

In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2), or once weekly for up to 24 weeks (Cohort C3 and C4), including a dose escalation period.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
2. Self-declaration of body weight change <5% within 3 months prior to informed consent ;

Exclusion criteria

1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
2. Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
3. Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
4. Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
7. Clinical laboratory test results with clinical significance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 6 patient groups, including a placebo group

oral ecnoglutide dose 1

Experimental group

Description:

once daily

Treatment:

Drug: ecnoglutide tablets

oral ecnoglutide dose 2

Experimental group

Description:

once daily

Treatment:

Drug: ecnoglutide tablets

oral ecnoglutide dose 3

Experimental group

Description:

once weekly

Treatment:

Drug: ecnoglutide tablets

oral ecnoglutide dose 4

Experimental group

Description:

once weekly

Treatment:

Drug: ecnoglutide tablets

placebo dose 1

Placebo Comparator group

Description:

once daily

Treatment:

Drug: placebo with matching dosage

placebo dose 2

Placebo Comparator group

Description:

once weekly

Treatment:

Drug: placebo with matching dosage