Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT05533632
- Phase
- PHASE4
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide — DRUGParticipants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks.
Study Details
This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).
Key Dates
- Start date
- Apr 25, 2022
- Status verified
- Sep 2025
- Primary completion
- Jan 18, 2024
- Completion
- Jan 18, 2024
Study Design
- Enrollment
- 104 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SemaglutideParticipants will receive semaglutide subcutaneous (s.c.) injection once weekly in a dose escalation manner for 24 weeks: 0.25 milligrams (mg) (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Primary Outcome Measure
Number of Adverse Events (AEs) [ Time Frame: From baseline (Day 1) up to 24 weeks ]
Related coverage on Hipa.ai
- Semaglutide Reduces HbA1c by 1.6% and Weight by 5.3 kg in Type 2 DiabetesSemaglutide · Feb 10, 2025 · ClinicalTrials.gov
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