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Completed

NCT Number: NCT06323174

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese People's Liberation Army General Hospital-Endocrinology, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female
  • Age 18 years or above at the time of signing the informed consent
  • Diagnosed with type 2 diabetes >=30 days before screening
  • HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening
  • Body mass index (BMI) >=23 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
  • Renal impairment with estimated Glomerular Filtration Rate 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 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
  • History of use of any injectable therapy for diabetes or obesity. 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 a fundus 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

Treatment and study plan

Cagrilintide

Drug

Participants will receive once-weekly cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive once-weekly semaglutide subcutaneously.

Placebo

Drug

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as percentage (%)-points.

Secondary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in %.

  2. Number of participants who achieve greater than or equal to (>=) 10% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as count of participants.

  3. Number of participants who achieve >=15% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as count of participants.

  4. Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])

    Time frame: At end of treatment (week 40)

    Measured as count of participants.

  5. Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)

    Time frame: At end of treatment (week 40)

    Measured as count of participants.

  6. Change in Fasting Plasma Glucose (FPG)

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in millimoles per liter (mmol/L).

  7. Number of participants who achieve >=5% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as count of participants.

  8. Number of participants who achieve >=20% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as count of participants.

  9. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in centimeters (cm).

  10. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in millimeters of mercury (mmHg).

  11. Change in diastolic blood pressure (DBP)

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in mmHg.

  12. Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  13. Ratio to baseline in lipids: Total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  14. Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  15. Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  16. Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  17. Ratio to baseline in lipids: Triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  18. Ratio to baseline in lipids: Free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  19. Ratio to baseline in lipids: Non-HDL cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  20. Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)

    Time frame: At end of study (week 52)

    Measured as count of participants.

  21. Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as ratio.

  22. Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10.

    Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1.

  23. Change in SF-36v2 score: Physical Component Summary score

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7.

  24. Change in SF-36v2 score: Mental Component Summary score

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7.

  25. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36).

  26. Change in leptin

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in nanograms per milliliter (ng/mL).

  27. Change in soluble leptin receptor

    Time frame: From baseline (week 0) to end of treatment (week 40)

    Measured in ng/mL.

  28. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)

    Measured as count of events.

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

    Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)

    Measured as count of episodes.

  30. 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 treatment + 7 weeks (week 47)

    Measured as count of episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise

Acronym: REIMAGINE 1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Apr 2, 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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