NCT06672172CompletedPhase 3
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, 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)
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 284 (actual)
- First submitted
- 1 Nov 2024
- Start date
- 25 Sept 2024
- Primary completion date
- 13 Nov 2025
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06672172
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 284
- From 25 Sept 2024 to the primary completion date, 13 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected allergy to the investigational drug or its components or excipients.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
Other illness
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
Other
- Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.