NNC0662-0419 and Birth Control Pills for Women with Obesity
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 64
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for women aged 18-64 with obesity or being overweight who are not able to become pregnant. Participants will receive the study drug NNC0662-0419, a birth control pill called Altavera, and acetaminophen.
Are You a Good Fit for This Trial?
You may be able to join if
I am a female assigned at birth.
I am between 18 and 64 years old.
I weigh 60 kg or more.
I am generally healthy except for being overweight or obese.
You may not be able to join if
I have a known allergy to the study medications.
I have used certain medications that affect metabolism recently.
I have any reasons not to use the birth control pill in the study.
I have taken hormone replacement therapy in the last 28 days.
I have had major stomach surgery that could affect absorption.
I have significant gastrointestinal disorders.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a ty…
The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female (sex assigned at birth) of non-childbearing potential.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body weight more than or equal to (≥) 60.0 kilogram (kg).
* Considered to be generally healthy, except for overweight or obesity, bas…
Inclusion Criteria:
* Female (sex assigned at birth) of non-childbearing potential.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body weight more than or equal to (≥) 60.0 kilogram (kg).
* Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Use of any medication containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), or amylin receptor agonism before screening.
* Any contraindications for the use of the oral contraception used in the study according to the Altavera Product Information.
* Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
* Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
* History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
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