| Trial ID: | L2494 |
| Source ID: | NCT06672172
|
| Associated Drug: |
Hrs-7535 Tablet
|
| Title: |
A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS-7535 tablet|DRUG: HRS-7535 tablet|DRUG: HRS-7535 tablet|DRUG: HRS-7535 placebo tablet
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c at 32 weeks of treatment, at 32 weeks | Secondary: Percentage of Participants Who Achieved HbA1c <7.0% at Week 32, at 32 weeks|Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32, at 32 weeks|Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32, at 32 weeks|Percentage Change from Baseline in Body Weight, from Baseline to Week 32, at 32 weeks|Change from Baseline in Body Weight, from Baseline to Week 32, at 32 weeks|Change from Baseline in Waist Circumference, from Baseline to Week 32, at 32 weeks
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
272
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-11
|
| Completion Date: |
2026-07
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-04
|
| Locations: |
Peking Union Medical College Hospital, Beijing, Beijing, 100730, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06672172
|
