A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
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What is this study?
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •You are male or female (sex assigned at birth, including all gender identities).
- •You are at least 18 years old when you sign the informed consent.
- •Your BMI is 35.0 kg/m² or higher.
- •If you do not have type 2 diabetes, you have no history of T2D and your HbA1c is below 6.5%.
- •If you do have type 2 diabetes, you have a history of T2D and your HbA1c is below 10%.
🚫 You may not be able to join if…
- •You reported a body weight change greater than 5% within 90 days before screening (no matter what the medical records show).
- •You used any GLP-1 receptor agonist (GLP-1 RA) medicine, including medicines with GLP-1 RA activity, within 6 months before screening.
- •You used an amylin analogue medicine, including medicines with amylin activity, within 6 months before screening.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults age 18 or older
- ✓BMI 35 or higher
- ✓Has obesity with or without type 2 diabetes (A1c must meet the study limits)
- ✓No recent major weight change (more than 5% within 90 days)
- ✓No GLP-1 medicines (or amylin-acting drugs) within 6 months before screening
- !May require a break from current GLP-1 medications
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 3 groups in this study.
What to expect, step by step
· This study lasts about 72 weeks (~17 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 72 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: Cagrisema
- Drug: Semaglutide
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Novo Nordisk A/S
Overseen by Clinical Transparency (dept. 2834)
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+
Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT07564414 · Locations: Alabama · Arizona · Arkansas · California · Colorado · Florida · Georgia · Idaho · Illinois · Iowa · Kansas