Actively Recruiting
Investigation of NNC0662-0419 Effects on Oral Contraceptive Pharmacokinetics and Gastric Emptying in Women With Overweight or Obesity
Led by Novo Nordisk A/S · Updated on 2026-04-24
45
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the drug NNC0662-0419 works together with birth control pills and affects stomach emptying in women who cannot become pregnant and have overweight or obesity. This phase 1 study aims to find out if NNC0662-0419 is safe and how it interacts with other medicines, including a birth control pill called Altavera and a mild painkiller, acetaminophen. The study includes women aged 18 to 64 years who weigh at least 60 kilograms and are generally healthy except for their weight condition. Participants will receive weekly injections of NNC0662-0419 using a pen injector over the treatment period. They will also take the oral contraceptive Altavera under supervision and a single dose of acetaminophen with a standardized meal during the treatment. The study measures how these medicines move through the body, focusing on the levels of the birth control hormones and how the stomach empties after eating. During the study, participants will undergo blood tests to measure the levels of the hormones ethinylestradiol and levonorgestrel and the painkiller acetaminophen at specific times after dosing. Researchers will monitor the participants' health through physical exams, vital signs, heart tests, and lab tests. The study will last through the treatment period with assessments before and after dosing to ensure safety and collect data on how the drugs are processed by the body.
CONDITIONS
Brief Title
A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (sex assigned at birth) of non-childbearing potential
- Age between 18 and 64 years inclusive at consent
- Body weight 60.0 kilograms or more
- Generally healthy except for overweight or obesity as confirmed by medical history, physical exam, vital signs, ECG, and lab tests at screening
You will not qualify if you...
- Known or suspected allergy to study drugs or related products
- Use of medications with GLP-1, GIP, or amylin receptor agonists before screening
- Contraindications to the oral contraceptive Altavera
- Use or planned use of hormone replacement therapy during the study
- Use of drugs affecting CYP metabolism within 14 days before screening, except routine vitamins and occasional mild painkillers
- Significant gastrointestinal disorders affecting drug or nutrient absorption
- History of major stomach surgery or current gastrointestinal implants affecting absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple weeks during treatment period
Participants receive once-weekly subcutaneous NNC0662-0419 injections, oral contraceptive tablets under supervision, and a single dose of acetaminophen during a standardized meal to study drug effects.
Weekly visits for dosing and assessments
Trial Site Locations
Total: 1 location
1
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States, 66212
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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