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

ConditionT2DM
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Raynovent Biotech Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Have type 1 diabetes mellitus

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;

History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;

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 ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAY1225

    Drug

    Administered SC

  • placebo

    Drug

    Administered SC

Treatment groups

350 Participants
are divided into 4 treatment groups
Group A: 3mg RAY1225Experimental treatment 1 intervention
Group B: 6mg RAY1225Experimental treatment 1 intervention
Group C: 9mg RAY1225Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A.

Time frame
Baseline,36 Week

Secondary outcomes

1

Percentage of Participants Achieving an HbA1c Target Value of <7%

Time frame
Baseline,36 Week
2

Percentage of Participants With HbA1c Target Value of <6.5%

Time frame
Baseline,36 Week
3

Mean change in fasting serum glucose

Time frame
Baseline,36 Week
4

Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline

Time frame
Baseline,36 Week

Other outcomes

Sponsors and contacts

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