NCT06732960

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Last Updated

April 2, 2025

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 5, 2024

Last Update Submit

April 1, 2025

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

  • Weight

    Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline

    Baseline, 4 weeks after the target dose

  • Adverse Event

    Numbers of Adverse Event

    Adverse events occurring within 4 weeks of the last dose from baseline

Secondary Outcomes (15)

  • Weight

    Baseline, 4 weeks after the target dose

  • BMI

    Baseline, 4 weeks after the target dose

  • Waist circumference

    Baseline, 4 weeks after the target dose

  • Hip circumference

    Baseline, 4 weeks after the target dose

  • Waist Hip Rate (WHR)

    Baseline, 4 weeks after the target dose

  • +10 more secondary outcomes

Study Arms (5)

Efsubaglutide Alfa 5mg

EXPERIMENTAL

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.

Biological: Efsubaglutide AlfaOther: Placebo

Efsubaglutide Alfa 7.5mg

EXPERIMENTAL

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.

Biological: Efsubaglutide AlfaOther: Placebo

Efsubaglutide Alfa 10mg

EXPERIMENTAL

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.

Biological: Efsubaglutide AlfaOther: Placebo

Efsubaglutide Alfa 15mg

EXPERIMENTAL

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.

Biological: Efsubaglutide AlfaOther: Placebo

Efsubaglutide Alfa 20mg

EXPERIMENTAL

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.

Biological: Efsubaglutide AlfaOther: Placebo

Interventions

Efsubaglutide AlfaBIOLOGICAL

Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.

Also known as: Supaglutide
Efsubaglutide Alfa 10mgEfsubaglutide Alfa 15mgEfsubaglutide Alfa 20mgEfsubaglutide Alfa 5mgEfsubaglutide Alfa 7.5mg
PlaceboOTHER

Placebo subcutaneous injection weekly

Efsubaglutide Alfa 10mgEfsubaglutide Alfa 15mgEfsubaglutide Alfa 20mgEfsubaglutide Alfa 5mgEfsubaglutide Alfa 7.5mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Friendship Hospital, Capital Medical University

Beijing, China, China

Location

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, China, China

Location

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

Shanghai, China, 200030, China

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Weiping Jia, M.D,Ph. D

    Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 13, 2024

Study Start

April 21, 2024

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

April 2, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)