OverweightPhase 3NCT06839664
A Study of HS-20094 in Chinese Adults With Overweight or Obesity
A Phase 3 study testing HS-20094 injection in people with Overweight and Obesity, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- HS-20094 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2024to 30 Jan 2026
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 65 years of age at the time of consent(cutoff value included).
- Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea.
- Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.
Who cannot join
- Diabetes mellitus
- Weight change >5.0% after diet and exercise control for at least 12 weeks before screening
- Have used or are currently using weight loss drugs within 3 months before screening
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2)
- History of moderate to severe depression, or have a history of serious mental illness
Show all 9Show fewer
- Any lifetime history of a suicide attempt
- Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
- Have a history of any malignancy within the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
Read the detailed description
This is a phase Ⅲ, 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) in China. Eligible participants were randomly assigned to receive once-weekly subcutaneous HS-20094 or placebo for 48 weeks. The co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.
- Conditions
- Overweight, Obesity
- Being tested
- HS-20094 injection, Placebo injection
- 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-20094 injectionDrug
Administered SC
Placebo injectionDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| HS-20094 5mg | Experimental | Not described Receives: Drug: HS-20094 injection |
| HS-20094 10mg | Experimental | Not described Receives: Drug: HS-20094 injection |
| HS-20094 15mg | Experimental | Not described Receives: Drug: HS-20094 injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
Measured: Baseline, week 48
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
Measured: Baseline, week 48
Secondary outcomes (3)
Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline
Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline
Measured: Baseline, week 4
Change in waist circumference from baseline at week 48
Change in waist circumference from baseline at week 48
Measured: Baseline, week 48
Percentage change in body weight from baseline at week 24
Percentage change in body weight from baseline at week 24
Measured: Baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start16 Nov 2024
- Primary completion4 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839664
- Sponsor's protocol ID
- HS-20094-301
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT06839664
- Acronym / sponsor ID
- HS-20094-301
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
Detailed description
This is a phase Ⅲ, 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) in China. Eligible participants were randomly assigned to receive once-weekly subcutaneous HS-20094 or placebo for 48 weeks. The co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-20094 5mg | Experimental | Drug: HS-20094 injection |
| HS-20094 10mg | Experimental | Drug: HS-20094 injection |
| HS-20094 15mg | Experimental | Drug: HS-20094 injection |
| Placebo | Placebo comparator | Drug: Placebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 to 65 years of age at the time of consent(cutoff value included).
- Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea.
- Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.
Key exclusion criteria (9 listed)
- Diabetes mellitus
- Weight change >5.0% after diet and exercise control for at least 12 weeks before screening
- Have used or are currently using weight loss drugs within 3 months before screening
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20094 injectionAdministered SC | Drug | HS-20094 10mg, HS-20094 15mg, HS-20094 5mg |
| Placebo injectionAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, week 48
Percent Change from Baseline in Body Weight
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
Time frame: Baseline, week 48
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
3 secondary outcomes
Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline
Time frame: Baseline, week 4
Change in waist circumference from baseline at week 48
Time frame: Baseline, week 48
Percentage change in body weight from baseline at week 24
Time frame: Baseline, week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20094 injection in people with Overweight and Obesity, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 9 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 8 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 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Baseline, week 48). 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?
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 8 Jun 2026.