Diabetes Mellitus, Type 2 study: CagriSema
Official title Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
ClinicalTrials.gov ID: NCT07817251
What this study is testing
What is CagriSema?
CagriSema is an investigational once-weekly injectable medicine being studied for type 2 diabetes. is designed to help control blood sugar levels by combining two medicines that affect hormones involved in appetite and insulin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if it is safe and well-tolerated to switch from semaglutide to CagriSema.
- Who it's for
- The study is looking for people who have type 2 diabetes.
- What's involved
- Participants will receive CagriSema, the treatment being tested.
- Time commitment
- The study lasts about 6 months.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.
- Stable once-weekly dose ≥ 90 days before screening of branded s.c. semaglutide. Branded semaglutide s.c. includes Ozempic and Wegovy.
- Not on treatment with oral antidiabetic drugs or on stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or...
You likely can't join if
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive...
- Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as...
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- A self-reported change in body weight \> 5% within 90 days before screening irrespective of medical records.
- Use of personal continuous glucose monitoring (CGM) devices. Participants currently using personal CGM devices must discontinue use prior to...
See the full eligibility criteria
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.
- Stable once-weekly dose ≥ 90 days before screening of branded s.c. semaglutide. Branded semaglutide s.c. includes Ozempic and Wegovy. Participants on compounded semaglutide are ineligible.
- Not on treatment with oral antidiabetic drugs or on stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen at effective or maximum tolerated dose (MTD) as...
- Glycated haemoglobin (HbA1c) 6.5-10.5 percentage (%) (48-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
- Body mass index (BMI) ≥ 25 kilograms per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method from screening.
- Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.
- A self-reported change in body weight \> 5% within 90 days before screening irrespective of medical records.
- Use of personal continuous glucose monitoring (CGM) devices. Participants currently using personal CGM devices must discontinue use prior to screening and throughout study participation.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Fountain Valley, California, United States
- Glendora, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Waterbury, Connecticut, United States
- Fleming Island, Florida, United States
- Hialeah, Florida, United States
- Mt. Dora, Florida, United States
- Orange City, Florida, United States
- West Palm Beach, Florida, United States
- Honolulu, Hawaii, United States
- Skokie, Illinois, United States
- West Des Moines, Iowa, United States
- Newton, Kansas, United States
- Topeka, Kansas, United States
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Fountain Valley, California, United States; Glendora, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Northridge, California, United States and 31 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.