A Phase 3 interventional study of NNC0487-0111 and Semaglutide in Obesity, Overweight and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Not yet recruiting at 120 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
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. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: NNC0487-0111 · Drug: Placebo (matched to semaglutide)
Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: Semaglutide · 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.
Semaglutide 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 pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to semaglutide will be administered subcutaneously using 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 centimeter (cm).
Time frame: From baseline (week 0) to week 84
Change in systolic blood pressure (SBP)
Measured as millimeter of mercury (mmHg).
Time frame: From baseline (week 0) to week 84
Change in body weight
Measured as kilograms (kg).
Time frame: From baseline (week 0) to week 84 and week 104
Change in body mass index (BMI)
Measured as kilograms per meter squared (kg/m\^2).
Time frame: From baseline (week 0) to week 84 and week 104
Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to week 84
Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to week 84
Number of participants with achievement of HbA1c < 5.7% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to week 84
Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)
Measured as mmol/L.
Time frame: From baseline (week 0) to week 84
Change in FPG measured as milligrams per deciliter (mg/dL)
Measured as mg/dL.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in fasting insulin
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in total cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in non-HDL cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in triglycerides
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio.
Time frame: From baseline (week 0) to week 84
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as events.
Time frame: From baseline (week 0) to week 84 and week 109
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as events.
Time frame: From baseline (week 0) to week 84 and week 109
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Time frame: From baseline (week 0) to week 84 and week 109
Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)
Measured as episodes.
Time frame: From baseline (week 0) to week 84 and week 109
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 episodes.
Time frame: From baseline (week 0) to week 84 and week 109
Showing the first 100 of 120 sites across 14 countries.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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