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NNC0487-0111 Formulations for Obesity

Phase 1

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

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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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).

0 / 1Eligibility criteria met