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NCT07139535Not yet recruitingPhase 3

A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
350 (estimated)
First submitted
11 Aug 2025
Start date
31 Aug 2025
Primary completion date
1 Dec 2026
Lead sponsor
Guangdong Raynovent Biotech Co., Ltd
NCT number
NCT07139535

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 350
  • From 31 Aug 2025 to the primary completion date, 1 Dec 2026
  • 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

  • History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
  • History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
  • Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);

Other illness

  • Have type 1 diabetes mellitus
  • Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).

Lab values

  • Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \<3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;

Other

  • Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;

Who the study is looking for

  • Have been diagnosed with type 2 diabetes mellitus (T2DM)
  • Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.
  • Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
  • Be of stable weight (±5%) for at least 12 weeks before screening

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingcunChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.