A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients (LIGHT)

Shanghai Yinnuo Pharmaceutical Technology

Status and phase: Completed; Phase 2

Conditions: Overweight or Obesity

Treatments: Other: Placebo; Biological: Efsubaglutide Alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT06732960

YN011-W201 (Other Identifier)

Details and patient eligibility

About

This is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa at difference dose range once-weekly in patients with Overweight or Obesity.

Full description

This study will look at the adverse events and the change in participants' body weight from the start of the study to the end. Weight loss in participants taking Efsubaglutide Alfa will be compared to weight loss in participants taking placebo.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fully understood the study, signed the informed consent.
• Male or female patients aged from 18 to 75 years at the time of signing informed consent.
• Body mass index (BMI) greater than or equal to 28 kg/sqm or greater than or equal to 24 kg/sqm with the presence of at least one of the following weight-related comorbidities: prediabetic state, hypertension, dyslipidemia, non-alcoholic steatohepatitis (NASH), obstructive sleep apnea or cardiovascular disease.
• A self-reported change in body weight less than 5% within 90 days before screening irrespective.

Exclusion criteria

• Glycated hemoglobin (HbA1c) greater than or equal to 6.5%, or previously diagnosed with type 1 diabetes or type 2 diabetes.
• Have history of clinically significant abnormal gastric emptying, severe chronic gastrointestinal diseases, long-term use of medications that directly affect gastrointestinal peristalsis, or gastrointestinal surgery within 6 months prior to screening, and deemed unsuitable for participation by the investigator.
• Have history of hyperthyroidism or hypothyroidism, or a thyroid-stimulating hormone (TSH) level below the lower limit or above 1.5 times the upper limit of the normal range.
• Calcitonin greater than or equal to 50 ng/L, or have history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B syndrome, or a related family history.
• Any other condition that, in the judgment of the researchers, may affect the patient's ability to provide informed consent or comply with the trial protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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50 participants in 5 patient groups

Efsubaglutide Alfa 5mg

Experimental group

Description:

10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.

Treatment:

Biological: Efsubaglutide Alfa

Other: Placebo

Efsubaglutide Alfa 7.5mg

Experimental group

Description:

10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.

Treatment:

Biological: Efsubaglutide Alfa

Other: Placebo

Efsubaglutide Alfa 10mg

Experimental group

Description:

10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.

Treatment:

Biological: Efsubaglutide Alfa

Other: Placebo

Efsubaglutide Alfa 15mg

Experimental group

Description:

10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.

Treatment:

Biological: Efsubaglutide Alfa

Other: Placebo

Efsubaglutide Alfa 20mg

Experimental group

Description:

10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.

Treatment:

Biological: Efsubaglutide Alfa

Other: Placebo