Trial · Interventional
RecruitingPhase 3Registry dataResearch Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 210 participants (estimated)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 16 Sept 2026
- Primary completion
- 9 Jun 2027 (estimated)
- Completion
- 21 Jul 2027 (estimated)
- First posted
- 14 Sept 2026
- Last update posted
- 30 Sept 2026
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
NCT0781725116 Sept 2026 to est. 21 Jul 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes. All participants will get CagriSema, the treatment being tested. Participants will be in this clinical study for about 6 months.
Interventions
- CagriSemaDrug
Arms3
Experimental
CagriSema dose 1
Participants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1.
Experimental
CagriSema dose 2
Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 2, followed by dose 1.
Experimental
CagriSema dose 3
Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 3, followed by dose 2 and dose 1.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of treatment emergent adverse events (TEAEs)
Time frame · From baseline (Week 0) to end of treatment (Week 16)
Registry description
Measured as count of events.
Secondary outcomes(7)
Number of TEAEs
Time frame · From baseline (Week 0) to end of study (Week 22)
Registry description
Measured as count of events.
Number of TEAEs
Time frame · From baseline (Week 0) to Week 8
Registry description
Measured as count of events.
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose [BG] meter)
Time frame · From baseline (Week 0) to end of study (Week 22)
Registry description
Measured as count of episodes.
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Time frame · From baseline (Week 0) to end of study (Week 22)
Registry description
Measured as count of episodes.
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Time frame · From baseline (Week 0) to Week 8
Registry description
Measured as count of episodes.
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Time frame · From baseline (Week 0) to Week 8
Registry description
Measured as count of episodes.
Number of participants who discontinued due to gastrointestinal (GI) adverse events (AEs)
Time frame · From baseline (Week 0) to end of treatment (Week 16)
Registry description
Measured as count of participants.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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