CagriSema for Type 2 Diabetes (REIMAGINE 1 Trial)

Phase 3

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of treatment + 7 weeks (week 47)

Awards & highlights

Pivotal Trial

Summary

This trial will investigate whether a new experimental medicine called CagriSema can help people with type 2 diabetes reduce their blood sugar and body weight. Participants will be randomly assigned to receive either C

Who is the study for?

This trial is for people with type 2 diabetes who manage their condition through diet and exercise. Participants will be involved in the study for about a year, receiving either the investigational medicine CagriSema or a placebo.

What is being tested?

The study tests how well CagriSema, an experimental medication not yet available by prescription, lowers blood sugar and body weight compared to a placebo—a treatment with no active effect on the body.

What are the potential side effects?

Potential side effects of CagriSema are not detailed here but may include those typical of diabetes medications such as nausea, low blood sugar levels (hypoglycemia), and digestive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of treatment +7 weeks (week 47)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of treatment +7 weeks (week 47)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of treatment +7 weeks (week 47) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in glycated haemoglobin (HbA1c)

Secondary study objectives

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Change in Fasting Plasma Glucose (FPG)

Change in SF-36v2 score: Mental Component Summary score

+27 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: CagriSema Dose 2Active Control2 Interventions

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.

Group II: Cagrisema Dose 1Active Control2 Interventions

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.

Group III: Placebo Dose 2Placebo Group1 Intervention

Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks.

Group IV: Placebo Dose 1Placebo Group1 Intervention

Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks.

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