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Overweight and ObesityPhase 2NCT06118021

A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

A Phase 2 study testing HS-20094 in people with Overweight and Obesity, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 2 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 of HS-20094 in participants with overweight and obesity. The main purpose is to learn more about how HS-20094 affects body weight. The study period including 4-12 weeks dose titration and 12-20 weeks maintain treatment and 6 weeks follow up. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
HS-20094
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
2 sitesChina
Study dates
16 Oct 2023to 13 Aug 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female subjects,18-65 years of age at the time of signing informed consent.
  • BMI≥28.0kg/m2 or 24≤BMI<28.0 kg/ m2 with at least 1 weight-related comorbidity at screening visit.
  • Diet and exercise control for at least 3 months before screening visit,and less than 5 kg self-reported change within the last 3 months.

Who cannot join

  • 1. Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
  • 2. poor-controlled hypertension. 3. PHQ-9 score≥15. 4. Medical history or illness that affects your weight. 5. Use of any medication or treatment that may have caused significant weight change within 3 months.
  • 6. History of bariatric surgery. 7. History of diabetes. 8. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
  • 9. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
  • 10. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix.
  • 11. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness.
Show all 11Show fewer
  • 12. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening.
  • 13. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening.
  • 14. Known or suspected hypersensitivity to trial product(s)or related products. 15. Female who is pregnant,breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
  • 16. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme,and their immediate family members.
  • 17. In the judgment of the investigator,there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • the Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 100044

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects

This is a study of HS-20094 in participants with overweight and obesity. The main purpose is to learn more about how HS-20094 affects body weight. The study period including 4-12 weeks dose titration and 12-20 weeks maintain treatment and 6 weeks follow up.

Read the detailed description

This is a phase 2, double-blind, randomised, placebo-controlled trial to assess the efficacy of HS-20094 in Chinese subjects with overweight or obesity. We enrolled adults (aged 18-65 years, both inclusive) with overweight (body-mass index [BMI] ≥24 kg/m2) accompanied by at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m2) from over 10 hospitals in China. Eligible participants were randomly assigned (4:1) within each cohort by using an interactive web-response system to receive once-weekly subcutaneous HS-20094 or placebo for 24 weeks in one of the 4 cohorts below：the 5 mg cohort (5 mg weeks 1-24) ，the 10 mg cohort（5 mg weeks 1-4，10 mg weeks 5-24），the 15 mg cohort（5 mg weeks 1-4，10 mg weeks 5-8,15 mg weeks 9-24），the 20 mg cohort（5 mg weeks 1-4，10 mg weeks 5-8，15 mg weeks 9-12，20 mg weeks 13-24）. The participants, investigators, study site personnel involved in treating and assessing participants in each cohort and sponsor personnel were masked to treatment allocation. The primary endpoints were the percent change in bodyweight from baseline and bodyweight reduction of 5% or higher. The secondary outcomes included the change from baseline to week 24 in waist circumference and BMI.

Being tested
HS-20094, 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.

  • HS-20094Drug

    Also called HS-20094 injection

    Administered SC

  • PlaceboDrug

    Also called Placebo injection

    Administered SC

Study groups in NCT06118021
Study groupRoleWhat they receive
HS-20094 5mgExperimentalDrug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.
Receives: Drug: HS-20094; Drug: Placebo
HS-20094 10mgExperimentalDrug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.
Receives: Drug: HS-20094; Drug: Placebo
HS-20094 15mgExperimentalDrug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.
Receives: Drug: HS-20094; Drug: Placebo
HS-20094 20mgExperimentalDrug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.
Receives: Drug: HS-20094; Drug: Placebo

What is being measured

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

  1. Percent Change from Baseline in Body Weight

    Percent Change from Baseline in Body Weight

    Measured: From Week 0 to Week 24

Secondary outcomes (9)

  1. Number of AEs During the Trial

    Safety

    Measured: From Week 0 to Week 24

  2. Change from Baseline in Patient Health Questionnaire-9 (PHQ-9)

    Measured: From Week 0 to Week 24

  3. Change from Baseline in Columbia Suicide Severity Rating scale ( C-SSRS)

    Measured: From Week 0 to Week 24

  4. 12-lead electrocardiogram (ECG) parameters: PR, R-R, QRS and QTcF (average)

    Measured: From Week 0 to Week 24

  5. Change from baseline in waist circumference after 24 weeks of treatment

    Measured: From Week 0 to Week 24

  6. Change from baseline in BMI after 24 weeks of treatment

    Measured: From Week 0 to Week 24

  7. Change from baseline in blood pressure after 24 weeks of treatment

    Measured: From Week 0 to Week 24

  8. Change from baseline in total cholesterol after 24 weeks of treatment

    Measured: From Week 0 to Week 24

  9. Change from baseline in fasting plasma glucose(FPG)after 24 weeks of treatment

    Measured: From Week 0 to Week 24

Timeline

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

  1. First posted7 Nov 2023
  2. Study start16 Oct 2023
  3. Primary completion13 Aug 2024
  4. Study completion13 Aug 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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118021
Sponsor's protocol ID
HS-20094-202
Status last verified
Jun 2026
First submitted
17 Oct 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-20094 in people with Overweight and Obesity, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 2 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 3 inclusion and 11 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Percent Change from Baseline in Body Weight (time frame: From Week 0 to Week 24). 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 NCT06118021.

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 4 Jun 2026.

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