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Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT07817251 (opens ClinicalTrials.gov in a new tab)Other idNN9388-8593Other idU1111-1332-8482

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
210 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
16 Sept 2026
Primary completion
9 Jun 2027 (estimated)
Completion
21 Jul 2027 (estimated)
First posted
14 Sept 2026
Last update posted
30 Sept 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 3

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

    NCT07817251

    16 Sept 2026 to est. 21 Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CagriSemaDrug

Arms3

  • Experimental

    CagriSema dose 1

    Participants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1.

  • Experimental

    CagriSema dose 2

    Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 2, followed by dose 1.

  • Experimental

    CagriSema dose 3

    Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 3, followed by dose 2 and dose 1.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment emergent adverse events (TEAEs)

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

    Registry description

    Measured as count of events.

Secondary outcomes(7)
  1. Number of TEAEs

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

    Registry description

    Measured as count of events.

  2. Number of TEAEs

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

    Registry description

    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)

    Registry description

    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)

    Registry description

    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

    Registry description

    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

    Registry description

    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)

    Registry description

    Measured as count of participants.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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