Type 2 DiabetesPhase 3OUTSTAND-1NCT06672172

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise

A Phase 3 study testing HRS-7535 tablet in people with Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site 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

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: HRS-7535 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 284 participants
Where: 1 siteChina
Study dates: 25 Sep 2024to 17 Apr 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, 18-75 age years, both inclusive;
Type 2 diabetes mellitus diagnosed for at least 2 months before the screening visit;
HbA1c 7.0-10.0% (both inclusive) at screening;
Treated with diet and exercise, and without any antidiabetic drugs at least 8 weeks prior to screening.

Who cannot join

Known or suspected allergy to the investigational drug or its components or excipients.
Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (OUTSTAND-1)

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise

Conditions: Type 2 Diabetes
Being tested: HRS-7535 tablet, HRS-7535 placebo tablet
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

HRS-7535 tabletDrug
HRS-7535 tablet; low dose
HRS-7535 tabletDrug
HRS-7535 tablet; middle dose
HRS-7535 tabletDrug
HRS-7535 tablet; high dose
HRS-7535 placebo tabletDrug
HRS-7535 placebo tablet

Study groups in NCT06672172
Study group	Role	What they receive
Treatment group A: subjects will receive HRS-7535 tablet orally at dose 1	Experimental	Not described Receives: Drug: HRS-7535 tablet
Treatment group B: subjects will receive HRS-7535 tablet orally at dose 2	Experimental	Not described Receives: Drug: HRS-7535 tablet
Treatment group C: subjects will receive HRS-7535 tablet orally at dose 3	Experimental	Not described Receives: Drug: HRS-7535 tablet
Treatment group D: subjects will receive HRS-7535 placebo tablet orally.	Placebo comparator	Not described Receives: Drug: HRS-7535 placebo tablet

What is being measured

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

Change from baseline in HbA1c at 32 weeks of treatment
Measured: at 32 weeks

Secondary outcomes (6)

Percentage of Participants Who Achieved HbA1c <7.0% at Week 32
Measured: at 32 weeks
Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32
Measured: at 32 weeks
Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32
Measured: at 32 weeks
Percentage Change from Baseline in Body Weight, from Baseline to Week 32
Measured: at 32 weeks
Change from Baseline in Body Weight, from Baseline to Week 32
Measured: at 32 weeks
Change from Baseline in Waist Circumference, from Baseline to Week 32
Measured: at 32 weeks

Timeline

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

25 Sep 202417 Apr 2026

First posted4 Nov 2024
Study start25 Sep 2024
Primary completion13 Nov 2025
Study completion17 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Shandong Suncadia Medicine 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: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06672172
Sponsor's protocol ID: HRS-7535-301
Acronym: OUTSTAND-1
Status last verified: May 2026
First submitted: 1 Nov 2024
Last updated: 22 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yu M, Peng L, Jiang C, Zhang X, Li Q, Zhang L, Su X, Zeng Z, Yan S, Wang J, Huang D, Wang S, Liu N, Xu Y, Tang G, Dong F, Ma Y, Ye Z, Xiao X; OUTSTAND-1 Investigator Group. Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Nat Med. 2026 Sep 29. doi: 10.1038/s41591-026-04651-9. Online ahead of print.
PubMed 42811187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (OUTSTAND-1)
ClinicalTrials.gov ID: NCT06672172
Acronym / sponsor ID: OUTSTAND-1 / HRS-7535-301
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 284 participants (actual)
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Sep 2024 (actual)
Primary completion: 13 Nov 2025 (actual)
Study completion: 17 Apr 2026 (actual)
First posted: 4 Nov 2024 (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 aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Treatment group A: subjects will receive HRS-7535 tablet orally at dose 1	Experimental	Drug: HRS-7535 tablet
Treatment group B: subjects will receive HRS-7535 tablet orally at dose 2	Experimental	Drug: HRS-7535 tablet
Treatment group C: subjects will receive HRS-7535 tablet orally at dose 3	Experimental	Drug: HRS-7535 tablet
Treatment group D: subjects will receive HRS-7535 placebo tablet orally.	Placebo comparator	Drug: HRS-7535 placebo tablet

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, 18-75 age years, both inclusive;
Type 2 diabetes mellitus diagnosed for at least 2 months before the screening visit;
HbA1c 7.0-10.0% (both inclusive) at screening;
Treated with diet and exercise, and without any antidiabetic drugs at least 8 weeks prior to screening.

Key exclusion criteria (5 listed)

Known or suspected allergy to the investigational drug or its components or excipients.
Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

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
HRS-7535 tabletHRS-7535 tablet; low dose	Drug	Treatment group A: subjects will receive HRS-7535 tablet orally at dose 1
HRS-7535 tabletHRS-7535 tablet; middle dose	Drug	Treatment group B: subjects will receive HRS-7535 tablet orally at dose 2
HRS-7535 tabletHRS-7535 tablet; high dose	Drug	Treatment group C: subjects will receive HRS-7535 tablet orally at dose 3
HRS-7535 placebo tabletHRS-7535 placebo tablet	Drug	Treatment group D: subjects will receive HRS-7535 placebo tablet orally.

Primary outcome

Change from baseline in HbA1c at 32 weeks of treatment
Time frame: at 32 weeks

6 secondary outcomes

Percentage of Participants Who Achieved HbA1c <7.0% at Week 32
Time frame: at 32 weeks
Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32
Time frame: at 32 weeks
Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32
Time frame: at 32 weeks
Percentage Change from Baseline in Body Weight, from Baseline to Week 32
Time frame: at 32 weeks
Change from Baseline in Body Weight, from Baseline to Week 32
Time frame: at 32 weeks
Change from Baseline in Waist Circumference, from Baseline to Week 32
Time frame: at 32 weeks

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 22 May 2026.
Derived from this study: PubMed 42811187Yu M, Peng L, Jiang C, Zhang X, Li Q, Zhang L, Su X, Zeng Z, Yan S, Wang J, Huang D, Wang S, Liu N, Xu Y, Tang G, Dong F, Ma Y, Ye Z, Xiao X; OUTSTAND-1 Investigator Group. Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Nat Med. 2026 Sep 29. doi: 10.1038/s41591-026-04651-9. Online ahead of print.
Individual participant dataSharing planned: Undecided

Related trials for Type 2 Diabetes

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Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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 HRS-7535 tablet in people with Type 2 Diabetes, run by Shandong Suncadia Medicine 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 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 22 May 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?

Change from baseline in HbA1c at 32 weeks of treatment (time frame: at 32 weeks). 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 NCT06672172, which also lists 1 linked publication.

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 22 May 2026.