A Phase 3 interventional study of NNC0487-0111 and Placebo (matched to NNC0487-0111) in Diabetes Mellitus, Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 74 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Exclusion Criteria:
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: NNC0487-0111
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: NNC0487-0111
Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: NNC0487-0111
Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: NNC0487-0111
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: Placebo (matched to NNC0487-0111)
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Relative change in body weight
Measured as percentage (%) of body weight.
Time frame: From baseline (week 0) to (week 84)
Change in waist circumference
Measured as centimetre (cm).
Time frame: From baseline (week 0) to (week 84)
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) of HbA1c.
Time frame: From baseline (week 0) to (week 84)
Change in systolic blood pressure (SBP)
Measured as millimetre of mercury (mmHg).
Time frame: From baseline (week 0) to (week 84)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.
Time frame: From baseline (week 0) to (week 84)
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
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 (SD) of 10. The physical functioning ranges from 19.0 to 57.6. Higher scores indicate better functional health and well-being.
Time frame: From baseline (week 0) to (week 84)
Change in body weight
Measured as kilogram (kg).
Time frame: From baseline (week 0) to (week 84)
Change in body mass index (BMI)
Measured as kilograms per meter squared (kg/m\^2).
Time frame: From baseline (week 0) to (week 84)
Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score
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. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.
Time frame: From baseline (week 0) to (week 84)
Achievement of HbA1c < 7.0% (Yes/No)
Measured as number of participants
Time frame: From baseline (week 0) to (week 84)
Achievement of HbA1c ≤ 6.5% (Yes/No)
Measured as number of participants
Time frame: From baseline (week 0) to (week 84)
Achievement of HbA1c < 5.7% (Yes/No)
Measured as number of participants
Time frame: From baseline (week 0) to (week 84)
Change in fasting plasma glucose (FPG) (mmol/L)
Measured as millimoles per liter (mmol/L)
Time frame: From baseline (week 0) to (week 84)
Change in fasting plasma glucose (FPG) (mg/dL)
Measured as milligram per deciliter (mg/dL)
Time frame: From baseline (week 0) to (week 84)
Change in fasting insulin
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in urinary albumin-to-creatinine ratio (UACR)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in diastolic blood pressure
Measured as mmHg.
Time frame: From baseline (week 0) to (week 84)
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to week 88
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as count of events.
Time frame: From baseline (week 0) to week 88
Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation
Measured as count of events.
Time frame: From baseline (week 0) to week 88
Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)
Measured as number of episodes
Time frame: From baseline (week 0) to week 88
Number of treatment emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Measured as number of episodes
Time frame: From baseline (week 0) to week 88
Change in Total cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in High-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in Low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in Very low-density lipoprotein (VLDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in Non-HDL cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Change in Triglycerides
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 84)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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