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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-64 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Awards & highlights
Summary
This trial involves two phases, Phase A and Phase B, where participants will be taking part in both phases. Phase A compares two different versions of a medication called NNC0487-0111 for
Who is the study for?
This trial is for individuals living with overweight or obesity. Participants must be willing to undergo two phases of the study, taking different oral formulations of a weight control medicine called NNC0487-0111. Specific eligibility criteria are not provided, but typically participants should be in stable health and meet certain body weight or BMI requirements.
What is being tested?
The study tests two different tablet formulations (C and D) of NNC0487-0111, assessing how they behave in the body and their effectiveness when taken with or without food. The trial randomly assigns one of these formulations to each participant over a period of approximately 5-6 months.
What are the potential side effects?
Since specific side effects are not listed for NNC0487-0111, common ones associated with new weight control medications may include gastrointestinal issues like nausea or diarrhea, headaches, dizziness, increased heart rate, or potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state
Secondary study objectives
Number of treatment emergent adverse events (TEAE)
Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state
Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Phase B: NNC0487-0111 (formulation D)Experimental Treatment1 Intervention
Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).
Group II: Phase A: NNC0487-0111 (formulation D)Experimental Treatment1 Intervention
Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks).
Group III: Phase B: NNC0487-0111 (formulation C)Active Control1 Intervention
Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).
Group IV: Phase A: NNC0487-0111 (formulation C)Active Control1 Intervention
Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks).
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,950 Total Patients Enrolled
151 Trials studying Obesity
143,242 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
123 Previous Clinical Trials
151,438 Total Patients Enrolled
36 Trials studying Obesity
50,634 Patients Enrolled for Obesity
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