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Anti-diabetic agent

NNC0487-0111 for Type 2 Diabetes

Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18-75 years at the time of signing the informed consent
Be older than 18 years old
Must not have
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy verified by a fundus examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 40)
Awards & highlights

Summary

This trial will test how effective different doses of a new medicine called NNC0487-0111 are in reducing blood sugar and body weight in people with type 2 diabetes. Participants will receive either

Who is the study for?
This trial is for individuals with type 2 diabetes who are interested in testing a new medication, NNC0487-0111. Participants will be involved in the study for approximately 43 weeks and must meet specific health criteria to join.
What is being tested?
The study tests how well different doses of NNC0487-0111 lower blood sugar and body weight when administered orally or by injection compared to a placebo. Treatment assignments are randomized.
What are the potential side effects?
Potential side effects of NNC0487-0111 may include typical drug reactions such as nausea, headache, dizziness, or allergic responses. Injection site reactions could occur with subcutaneous administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe diabetic eye problems that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 40)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 40) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c
Secondary outcome measures
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
Change in Urinary Albumin/Creatinine Ratio (UACR)
Change in average 24-hour systolic blood pressure (SBP)
+14 more

Trial Design

11Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC0487-0111 subcutaneous dose 6Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 6 treatment
Group II: NNC0487-0111 subcutaneous dose 5Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 5 treatment
Group III: NNC0487-0111 subcutaneous dose 4Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 4 treatment
Group IV: NNC0487-0111 subcutaneous dose 3Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 3 treatment
Group V: NNC0487-0111 subcutaneous dose 2Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 2 treatment
Group VI: NNC0487-0111 subcutaneous dose 1Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 1 treatment
Group VII: NNC0487-0111 oral dose 3Experimental Treatment1 Intervention
NNC0487-0111 oral dose 3 treatment
Group VIII: NNC0487-0111 oral dose 2Experimental Treatment1 Intervention
NNC0487-0111 oral dose 2 treatment
Group IX: NNC0487-0111 oral dose 1Experimental Treatment1 Intervention
NNC0487-0111 oral dose 1 treatment
Group X: Placebo oralPlacebo Group1 Intervention
Placebo for oral treatment
Group XI: Placebo subcutaneousPlacebo Group1 Intervention
Placebo for subcutaneous treatment

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,638 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
123 Previous Clinical Trials
151,126 Total Patients Enrolled
~288 spots leftby Sep 2025
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