CagriSema for Type 2 Diabetes

(REIMAGINE 1 Trial)

Recruiting in Palo Alto (17 mi)

+53 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

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 2 3 4 5}

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. ^{2 5 6 7 8}

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 5 6 9}

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

I am 18 years old or older.

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

I am either male or female.

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.

Treatment Details

Interventions

• Cagrilintide (Other)
• Placebo (Placebo)
• Semaglutide (GLP-1 Receptor Agonist)

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.

Participant Groups

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

Findings from Research

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]

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 (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]

References

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]