Obesity, Overweight, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGNNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
DRUGSemaglutide
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.
DRUGPlacebo (matched to semaglutide)
Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening. * Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening. Key
Exclusion criteria
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 milliliter (mL)/ minute (min)/1.73 meter squared (m\^2) (2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula), at screening. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to week 84 | Measured as percentage of body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to week 84 and week 109 | Measured as events. |
| Number of Treatment Emergent Serious Adverse Events (TESAEs) | From baseline (week 0) to week 84 and week 109 | Measured as events. |
| Number of TEAEs leading to permanent treatment discontinuation | From baseline (week 0) to week 84 and week 109 | Measured as events. |
| Change in waist circumference | From baseline (week 0) to week 84 | Measured as centimeter (cm). |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to week 84 | Measured as millimeter of mercury (mmHg). |
| Change in body weight | From baseline (week 0) to week 84 and week 104 | Measured as kilograms (kg). |
| Change in body mass index (BMI) | From baseline (week 0) to week 84 and week 104 | Measured as kilograms per meter squared (kg/m\^2). |
| Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no) | From baseline (week 0) to week 84 | Measured as count of participants. |
| Number of participants with achievement of HbA1c ≤ 6.5% (yes/no) | From baseline (week 0) to week 84 | Measured as count of participants. |
| Number of participants with achievement of HbA1c < 5.7% (yes/no) | From baseline (week 0) to week 84 | Measured as count of participants. |
| Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L) | From baseline (week 0) to week 84 | Measured as mmol/L. |
| Change in FPG measured as milligrams per deciliter (mg/dL) | From baseline (week 0) to week 84 | Measured as mg/dL. |
| Ratio to baseline: change in fasting insulin | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR) | From baseline (week 0) to week 84 | Measured as ratio. |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to week 84 | Measured as mmHg. |
| Ratio to baseline: change in total cholesterol | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in non-HDL cholesterol | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in triglycerides | From baseline (week 0) to week 84 | Measured as ratio. |
| Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to week 84 | Measured as ratio. |
| 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) | From baseline (week 0) to week 84 and week 109 | Measured as episodes. |
| 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 | From baseline (week 0) to week 84 and week 109 | Measured as episodes. |
Countries
Argentina, Brazil, Bulgaria, Croatia, Germany, Hungary, India, Mexico, Poland, Portugal, Romania, Thailand, Turkey (Türkiye), United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed