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NCT Number: NCT07817251

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gilbert Center For Family Medicine, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cagrisema

Drug

CagriSema will be administered s.c. once weekly.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From baseline (Week 0) to end of treatment (Week 16)

    Measured as count of events.

Secondary outcomes

  1. Number of TEAEs

    Time frame: From baseline (Week 0) to end of study (Week 22)

    Measured as count of events.

  2. Number of TEAEs

    Time frame: From baseline (Week 0) to Week 8

    Measured as count of events.

  3. Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose [BG] meter)

    Time frame: From baseline (Week 0) to end of study (Week 22)

    Measured as count of episodes.

  4. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame: From baseline (Week 0) to end of study (Week 22)

    Measured as count of episodes.

  5. Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter)

    Time frame: From baseline (Week 0) to Week 8

    Measured as count of episodes.

  6. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame: From baseline (Week 0) to Week 8

    Measured as count of episodes.

  7. Number of participants who discontinued due to gastrointestinal (GI) adverse events (AEs)

    Time frame: From baseline (Week 0) to end of treatment (Week 16)

    Measured as count of participants.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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