Not yet recruitingNCT07929298ClinicalTrials.gov record

A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

Overweight , Obesity · Weight Management

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 2
Age range: 18 years - 65 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 180 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Read the full description

In this study, eligible participants will be randomized to one of the four cohorts to receive either oral ecnoglutide tablet or placebo for up to 24 weeks, including a dose escalation period.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. At the time of informed consent, BMI≥28.0 kg/m\^2 regardless of comorbidities, or 24.0kg/m\^2≤BMI\<28.0 kg/m\^2 with at least one of the comorbidities (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, weight-bearing joint pain, etc.);
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 C-TIRADS≥ class 4A), Medullary thyroid carcinoma, 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 myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, unstable angina, transient ischemic attack, acute stroke, acute coronary syndrome, congestive heart failure classified as New York Heart Association class III or IV, clinically significant arrhythmias requiring treatment, and cerebrovascular accidents, etc.
4. Diagnosis of gastrointestinal diseases with clinical significance within 6 months prior to screening, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, 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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Quadruple masked

oral ecnoglutide dose 1

once daily from week1 to week 8, then once weekly from week 9 to week 24

Drug: ecnoglutide tablet

oral ecnoglutide dose 2

once daily from week1 to week 8, then once weekly from week 9 to week 24

Drug: ecnoglutide tablet

oral ecnoglutide dose 3

once daily from week1 to week 12, then once weekly from week 13 to week 24

Drug: ecnoglutide tablet

Placebo

once daily from week1 to week 8 or week 12, then once weekly from week 9 or week 13 to week 24

Drug: placebo with matching dosage

oral ecnoglutide dose 4

once daily from week1 to week 12, then once weekly from week 13 to week 24

Drug: ecnoglutide tablet

ecnoglutide tablet DRUG

oral tablet

placebo with matching dosage DRUG

oral tablet

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