CagriSema for Type 2 Diabetes

(REIMAGINE 1 Trial)

Recruiting at 55 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must not be taking: Diabetes medications

Disqualifiers: Pregnancy, Renal impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 40 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking any medication for diabetes or obesity 90 days before screening, except for short-term insulin treatment for up to 14 days or insulin for gestational diabetes.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any diabetes or obesity medications at least 90 days before joining the trial, except for short-term insulin treatment for up to 14 days or insulin for gestational diabetes.

What safety data is available for CagriSema in treating Type 2 Diabetes?

The safety data for CagriSema, which includes semaglutide, shows that it is generally well-tolerated with a safety profile similar to other GLP-1 receptor agonists. Clinical trials, such as the PIONEER and SUSTAIN programs, have evaluated semaglutide's safety, focusing on cardiovascular safety, gastrointestinal side effects, and other potential risks like hypoglycemia, pancreatic and thyroid cancer, gallbladder events, and diabetic retinopathy complications. Most adverse effects are mild to moderate and transient, with no unexpected safety issues reported. The overall risk/benefit profile is favorable for patients with Type 2 Diabetes. ^{1 2 3 4 5}

Is CagriSema safe for humans?

Semaglutide, a component of CagriSema, has been studied extensively and is generally considered safe, with most side effects being mild to moderate, such as stomach issues. It may increase the risk of gallbladder problems, and patients with certain eye conditions should be monitored closely, but no unexpected safety issues have been found. ^{1 2 3 4 5}

Is the drug Cagrilintide, Semaglutide a promising treatment for Type 2 Diabetes?

Yes, Cagrilintide, Semaglutide is a promising treatment for Type 2 Diabetes. It helps lower blood sugar levels and body weight, which are important for managing the disease. It is available in both injectable and oral forms, making it convenient for different patient needs. Clinical trials have shown it to be effective and safe, offering better glucose control and weight loss compared to other treatments. ^{1 2 3 6 7}

What makes the drug CagriSema unique for treating type 2 diabetes?

CagriSema combines two components, cagrilintide and semaglutide, which work together to improve blood sugar control and promote weight loss. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue that stimulates insulin release, while cagrilintide is an amylin analogue that helps regulate appetite, making this combination a novel approach compared to other treatments. ^{1 2 3 6 7}

What data supports the idea that CagriSema for Type 2 Diabetes is an effective drug?

The available research shows that combining semaglutide with cagrilintide (CagriSema) has weight-loss benefits for people with type 2 diabetes. While the specific impact on blood sugar levels is not detailed, semaglutide alone has been shown to effectively lower blood sugar and body weight. Compared to other treatments, oral semaglutide provides better control of blood sugar and helps reduce body weight, even in patients with more advanced diabetes. This suggests that CagriSema could be an effective option for managing type 2 diabetes. ^{1 3 6 8 9}

What data supports the effectiveness of the drug CagriSema for type 2 diabetes?

Research shows that semaglutide, a component of CagriSema, effectively lowers blood sugar and body weight in people with type 2 diabetes. Additionally, combining semaglutide with cagrilintide (CagriSema) has shown weight-loss benefits, although its impact on blood sugar control is still being studied. ^{1 3 6 8 9}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

HbA1c 7.0-9.5 percent (53-80 mmol/mol) as determined by central laboratory at screening

I am either male or female.

I was diagnosed with type 2 diabetes more than 30 days ago.

Exclusion Criteria

My kidney function is low, with a filtration rate under 30 ml/min.

I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

I haven't taken diabetes or obesity drugs in the last 90 days, except for short insulin uses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly subcutaneous injections of CagriSema or placebo. Dose escalation occurs over 8 to 16 weeks, followed by maintenance for up to 40 weeks.

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and hypoglycemic episodes.

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cagrilintide
• Placebo
• Semaglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: CagriSema Dose 2 Active Control 2 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 1 Active Control 2 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 2 Placebo Group 1 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 1 Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Published Research Related to This Trial

In a phase 3 trial involving 388 treatment-naive patients with type 2 diabetes, semaglutide significantly reduced HbA1c levels by 1.45% with 0.5 mg and 1.55% with 1.0 mg doses compared to placebo, indicating its efficacy in improving glycaemic control.

Semaglutide also led to significant weight loss, with reductions of 3.73 kg and 4.53 kg for the respective doses, while maintaining a safety profile similar to existing GLP-1 receptor agonists, with most adverse events being mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Sorli, C., Harashima, SI., Tsoukas, GM., et al.[2022]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Oral semaglutide, particularly at doses of 14 mg or flexibly dosed, significantly reduced HbA1c levels and body weight in patients with type 2 diabetes compared to other treatments, especially in those with higher baseline HbA1c levels.

The safety profile of oral semaglutide was comparable to that of other treatments, although it was associated with a higher incidence of gastrointestinal adverse events, which were consistent across different patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Aroda, VR., Bauer, R., Christiansen, E., et al.[2022]

In a 32-week trial with 92 participants, the combination of semaglutide and cagrilintide (CagriSema) led to a significant reduction in HbA1c levels compared to cagrilintide alone, indicating improved glycemic control in individuals with type 2 diabetes.

CagriSema also resulted in greater weight loss compared to both semaglutide and cagrilintide, demonstrating its potential as an effective treatment option for managing weight and blood sugar levels in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Frias, JP., Deenadayalan, S., Erichsen, L., et al.[2023]

Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

Semaglutide, a GLP-1 receptor agonist for type 2 diabetes, has a good safety profile but is associated with a high prevalence of gastrointestinal disorders, reported in over 3500 cases (53.2%).

Compared to other diabetes medications like sitagliptin and empagliflozin, semaglutide has a significantly higher number of reported gastrointestinal adverse events, indicating the need for careful monitoring in certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. Cabral Lopes, A., Roque, F., Lourenço, O., et al.[2023]

Semaglutide, a GLP-1 receptor agonist, has been shown to effectively improve blood sugar control and promote weight loss, with a favorable safety profile similar to other GLP-1RAs, based on extensive phase 3 trials including cardiovascular outcome studies.

The most common side effects of semaglutide are mild-to-moderate gastrointestinal disturbances, and while there are concerns about pancreatic and thyroid cancer, no unexpected safety issues have been identified, making it a beneficial option for patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Semaglutide. Smits, MM., Van Raalte, DH.[2023]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. [2022]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Semaglutide. [2023]

9. Belgium pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]