- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07710729
A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant
21. august 2026 opdateret af: Novo Nordisk A/S
A Single-Centre, Open-Label Study of the Effect of UBT251 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-Childbearing Potential With Overweight or Obesity
The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H3P 3P1
- Rekruttering
- Altasciences Clinical Company, Inc
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Female (sex assigned at birth) of NCBP.
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0-39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight >= 60.0 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.
- Treatment with any compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
- Any contraindications for the use of the oral contraception used in the study according to the PORTIA 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 cytochrome P450 (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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: UBT251
UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level.
|
Administered subcutaneously.
|
|
Eksperimentel: Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN])
An oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics.
|
Administered orally.
|
|
Eksperimentel: Acetaminophen (equivalent to paracetamol [para])
A single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying
|
Indgives oralt.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state
Tidsramme: From pre-dose on Day 8 up to 157 days
|
Measured in hours picograms per millilitre (h*pg/mL).
|
From pre-dose on Day 8 up to 157 days
|
|
AUC ,LN,SS: The area under the LN plasma concentration time curve during a dosing interval at steady state
Tidsramme: From pre-dose on Day 8 up to 157 days
|
Measured in h*pg/mL.
|
From pre-dose on Day 8 up to 157 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cmax,EE,SS: Maximum EE plasma concentration at steady state
Tidsramme: From pre-dose on Day 8 up to 157 days
|
Measured in picograms per millilitre (pg/mL).
|
From pre-dose on Day 8 up to 157 days
|
|
Cmax,LN,SS: Maximum LN plasma concentration at steady state
Tidsramme: From pre-dose on Day 8 up to 157 days
|
Measured in pg/mL.
|
From pre-dose on Day 8 up to 157 days
|
|
AUC,para: The area under the acetaminophen plasma concentration-time curve
Tidsramme: From pre-dose on Day 1 up to 150 days
|
Measured in hour microgram per millilitre (h*μg/mL).
|
From pre-dose on Day 1 up to 150 days
|
|
Cmax,para: Maximum observed acetaminophen plasma concentration
Tidsramme: From pre-dose on Day 1 up to 150 days
|
Measured in microgram per millilitre (μg/mL).
|
From pre-dose on Day 1 up to 150 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. juli 2026
Primær færdiggørelse (Anslået)
27. april 2027
Studieafslutning (Anslået)
27. april 2027
Datoer for studieregistrering
Først indsendt
13. juli 2026
Først indsendt, der opfyldte QC-kriterier
13. juli 2026
Først opslået (Faktiske)
17. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Lægemidlers fysiologiske virkninger
- Reproduktionskontrolmidler
- Præventionsmidler, kvinder
- Præventionsmidler
- Organiske kemikalier
- Farmakologiske handlinger
- Kemiske handlinger og anvendelser
- Terapeutiske anvendelser
- Anilider
- Amider
- Anilinforbindelser
- Aminer
- Acetanilider
- Acetaminophen
- Præventionsmidler, Oral
Andre undersøgelses-id-numre
- NN9559-8619
- U1111-1332-9333 (Anden identifikator: World Health Organization (WHO))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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