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Overweight or ObesityPhase 2LIGHTNCT06732960

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

A Phase 2 study testing Efsubaglutide Alfa in people with Overweight or Obesity, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Overweight or Obesity
What is being tested?
Efsubaglutide Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
3 sitesChina
Study dates
21 Apr 2024to 18 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, China

  • Jinan Central Hospital Affiliated to Shandong First Medical University

    Jinan, China

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

    Shanghai, China, 200030

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-controlled Study of Efsubaglutide Alfa on Weight Management in Subjects With Overweight or Obesity to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy.

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.

Read the detailed 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.

Being tested
Efsubaglutide Alfa, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efsubaglutide AlfaBiological

    Also called Supaglutide

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

  • PlaceboOther

    Placebo subcutaneous injection weekly

Study groups in NCT06732960
Study groupRoleWhat they receive
Efsubaglutide Alfa 5mgExperimental10 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.
Receives: Biological: Efsubaglutide Alfa; Other: Placebo
Efsubaglutide Alfa 7.5mgExperimental10 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.
Receives: Biological: Efsubaglutide Alfa; Other: Placebo
Efsubaglutide Alfa 10mgExperimental10 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.
Receives: Biological: Efsubaglutide Alfa; Other: Placebo
Efsubaglutide Alfa 15mgExperimental10 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.
Receives: Biological: Efsubaglutide Alfa; Other: Placebo
Efsubaglutide Alfa 20mgExperimental10 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.
Receives: Biological: Efsubaglutide Alfa; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

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

    Measured: Baseline, 4 weeks after the target dose

  2. Adverse Event

    Numbers of Adverse Event

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

Secondary outcomes (15)

  1. Weight

    Proportion of subjects with a weight loss of ≥10% or ≥15% from baseline, Change from baseline in weight

    Measured: Baseline, 4 weeks after the target dose

  2. BMI

    Change from baseline in BMI

    Measured: Baseline, 4 weeks after the target dose

  3. Waist circumference

    Change from baseline in Waist circumference

    Measured: Baseline, 4 weeks after the target dose

  4. Hip circumference

    Change from baseline in Hip circumference

    Measured: Baseline, 4 weeks after the target dose

  5. Waist Hip Rate (WHR)

    Change from baseline in Waist Hip Rate (WHR)

    Measured: Baseline, 4 weeks after the target dose

  6. Diastolic pressure

    Change from baseline in Diastolic pressure

    Measured: Baseline, 4 weeks after the target dose

  7. Systolic pressure

    Change from baseline in Systolic pressure

    Measured: Baseline, 4 weeks after the target dose

  8. Triglyceride

    Change from baseline in Triglyceride

    Measured: Baseline, 4 weeks after the target dose

  9. Total Cholesterol

    Change from baseline in Total Cholesterol

    Measured: Baseline, 4 weeks after the target dose

  10. High Density Lipoprotein Cholesterol （HDL-C）

    Change from baseline in High Density Lipoprotein Cholesterol （HDL-C）

    Measured: Baseline, 4 weeks after the target dose

  11. Low-Density Lipoprotein Cholesterol （LDL-C）

    Change from baseline in Low-Density Lipoprotein Cholesterol （LDL-C）

    Measured: Baseline, 4 weeks after the target dose

  12. HbA1c

    Change from baseline in HbA1c

    Measured: Baseline, 4 weeks after the target dose

  13. Fasting Blood Insulin

    Change from baseline in Fasting Blood Insulin

    Measured: Baseline, 4 weeks after the target dose

  14. HOMA-IR

    Change from baseline in HOMA-IR

    Measured: Baseline, 4 weeks after the target dose

  15. Body Fat

    Change in body fat from baseline measured with a body fat scale.

    Measured: Baseline, 4 weeks after the target dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start21 Apr 2024
  3. Primary completion18 Nov 2024
  4. Study completion18 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732960
Sponsor's protocol ID
YN011-W201
Other IDs
YN011-W201
Acronym
LIGHT
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efsubaglutide Alfa in people with Overweight or Obesity, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Baseline, 4 weeks after the target dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06732960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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