RecruitingPhase 3

Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema

Safety And Tolerability of 3 Switch Regimens From Semaglutide 1.0 mg and 2.0 mg to Co-Administered Cagrilintide and Semaglutide (Cagrisema) in Participants With Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be in this clinical study for about 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe it is to switch from semaglutide to CagriSema and how well people handle the switch. It is for adults with type 2 diabetes who take semaglutide. Everyone will get CagriSema and be in the study for about 6 months.

The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes. All participants will get CagriSema, the treatment being tested. Participants will be in this clinical study for about 6 months.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older. People of all gender identities may join.
  • Have had type 2 diabetes for at least 180 days before screening.
  • Have taken the same once-weekly dose of Ozempic or Wegovy for at least 90 days before screening. These are semaglutide shots under the skin. Compounded semaglutide is not allowed.
  • Take no diabetes pills, or take only metformin, an SGLT2 inhibitor (a type of diabetes medicine), or both. Daily doses must be unchanged for at least 90 days and judged effective or the highest you can tolerate by the study doctor.
  • Have an HbA1c of 6.5% to 10.5% at screening. This blood test measures your average blood sugar.
  • Have a BMI of at least 25 at screening. BMI is a measure based on your height and weight.

Who can't join

  • Be pregnant, breastfeeding, or planning to become pregnant. If you can become pregnant, you must use highly effective birth control starting at screening.
  • Have very low kidney function: an eGFR below 30 at screening. This test measures how well your kidneys filter blood.
  • Have used other diabetes or weight-loss medicines within 90 days before screening. Insulin use for up to 14 days in a row is allowed, as is past insulin use for diabetes during pregnancy.
  • Have uncontrolled and possibly unstable eye damage from diabetes. An eye exam must check this within 90 days before screening or between screening and assignment to treatment.
  • Report a weight change of more than 5% within 90 days before screening.
  • Use a personal continuous glucose monitor, a device that tracks blood sugar. You must stop using it before screening and for the whole study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 judged by the investigator: metformin and/or sodiumglucose co-transporter-2 (SGLT2) inhibitor. * 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. Exclusion criteria: * 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. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * 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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * 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.

Study sites (40)

AZ

CA

CT

FL

HI

IA

IL

KS

MI

NC

NM

NV

OH

TN

TX

UT

VA