A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant

Sponsor
Novo Nordisk A/S
Study ID
NCT06461039
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0487-0111 A — DRUG
    NNC0487-0111 A will be administered subcutaneously.
  • NNC0487-0111 C — DRUG
    NNC0487-0111 C will be taken orally.
  • Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) — DRUG
    Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.
  • Acetaminophen - 500 mg/15 ml — DRUG
    Acetaminophen - 500 mg/15 ml will be taken orally.

Study Details

This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.

Key Dates

Start date
Jun 14, 2024
Status verified
May 2025
Primary completion
Mar 16, 2025
Completion
Apr 4, 2025

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0487-0111
    Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.

Primary Outcome Measure

The area under the ethinylestradiol plasma concentration time curve at steady state [ Time Frame: Day 8 and Day 193 ]

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