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NCT Number: NCT07220642

Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIPREC Pueyrredon, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
  • Female or male (sex at birth)
  • Age 18 years or above at the time of signing the informed consent
  • History of at least one self-reported unsuccessful dietary effort to lose body weight (a*)
  • Body mass index (BMI) greater than or equal to >= 30.0 kilogram per square meter (kg/m^2), or BMI greater than or equal to >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a*)

Exclusion criteria

  • History of type 1 or type 2 diabetes (a*)
  • Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a*)
  • Previous dosing of marketed or non-marketed amylin-based compounds (a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Placebo

Drug

Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Primary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as percentage (%).

Secondary outcomes

  1. Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants.

  2. Number of participants with achievement of >= 15 % body weight reduction (yes/no)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants.

  3. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as centimeters (cm).

  4. Ratio to baseline in triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  5. Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  6. Relative change in visceral abdominal fat volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  7. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

  8. Change in Systolic Blood Pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as millimeter of mercury (mmHg).

  9. Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as kilograms (kg).

  10. Number of participants with achievement of >= 5 % body weight reduction (yes/no)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants.

  11. Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. 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 physical component summary score ranges from 6.1 to 79.7.

  12. Change in SF-36v2® mental component summary score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. 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 mental component summary score ranges from -3.8 to 78.7.

  13. Change in IWQOL-Lite-CT total score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.

  14. Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT Physical Function score (yes/no)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants. IWQOL-Lite-CT measures weight related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

  15. Change in Diastolic Blood Pressure (DBP)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mmHg.

  16. Ratio to baseline of total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  17. Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  18. Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  19. Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  20. Ratio to baseline of non-HDL cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  21. Ratio to baseline of free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  22. Change in glycated haemoglobin (HbA1c) percentage-points (%-points)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %-points.

  23. Change in HbA1c millimoles per mole (mmol/mol)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mmol/mol.

  24. Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mmol/L.

  25. Change in FPG milligrams per deciliter (mg/dL)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mg/dL.

  26. Ratio to baseline in fasting serum insulin

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  27. Number of treatment emergent adverse events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 71)

    Measured as count of events.

  28. Number of treatment emergent serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to end of study (week 71)

    Measured as count of events.

  29. Relative change from baseline in ectopic fat percentage: Liver fat

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  30. Relative change from baseline in ectopic fat percentage: Pancreatic fat

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  31. Relative change from baseline in ectopic fat percentage: Thigh muscle fat

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  32. Relative to baseline change in subcutaneous abdominal fat volume to abdominal non-fat volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  33. Relative to baseline change in visceral abdominal fat volume to abdominal non-fat volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  34. Relative to baseline change in subcutaneous fat (percent relative to total thigh volume)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  35. Relative to baseline change in intramuscular fat (percent relative to total thigh volume)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  36. Relative to baseline change in intermuscular fat (percent relative to total thigh volume)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  37. Relative to baseline change in contractile thigh muscle (percent relative to total thigh volume)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  38. Relative to baseline change in total thigh muscle volume to total thigh fat volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  39. Relative to baseline change in contractile thigh muscle volume to total thigh fat volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  40. Relative to baseline change in contractile thigh muscle volume to inter and intramuscular thigh fat volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

  41. Relative change from baseline in total fat volume to total lean volume

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity

Acronym: RENEW 1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
Jun 30, 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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