Une étude des injections sous-cutanées d'ABBV-295 pour évaluer les événements indésirables et la pharmacocinétique chez des participants adultes atteints d'obésité
Étude de phase 1b visant à évaluer la sécurité, la tolérabilité, la pharmacocinétique, l'immunogénicité et la pharmacodynamie de doses sous-cutanées multiples d'ABBV-295 chez des sujets adultes souffrant d'obésité
This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Anaheim, California, États-Unis, 92801
- CenExel Act- Anaheim Clinical Trials /ID# 283200
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Illinois
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Grayslake, Illinois, États-Unis, 60030
- Acpru /Id# 278624
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- BMI ≥ 30.0 to ≤ 45.0 kg/m2 after rounding to the tenths decimal at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
- A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
Exclusion Criteria:
- Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.
- HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.
- Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 3 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 4 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Expérimental: ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Délai: Up to approximately 194 days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. |
Up to approximately 194 days
|
|
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Délai: Up to approximately 194 days
|
Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed. |
Up to approximately 194 days
|
|
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Délai: Up to approximately 194 days
|
12-lead resting ECG will be recorded. |
Up to approximately 194 days
|
|
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Délai: Up to approximately 194 days
|
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed. |
Up to approximately 194 days
|
|
Maximum Observed Plasma Concentration (Cmax) of ABBV-295
Délai: Up to approximately 194 days
|
Cmax of ABBV-295 |
Up to approximately 194 days
|
|
Time to Cmax (Tmax) of ABBV-295
Délai: Up to approximately 194 days
|
Tmax of ABBV-295 |
Up to approximately 194 days
|
|
Trough plasma concentration (Ctrough) of ABBV-295
Délai: Up to approximately 194 days
|
Ctrough of ABBV-295 |
Up to approximately 194 days
|
|
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
Délai: Up to approximately 194 days
|
BETA of ABBV-295 |
Up to approximately 194 days
|
|
Terminal phase elimination half-life (t1/2) of ABBV-295
Délai: Up to approximately 194 days
|
t1/2 of ABBV-295 |
Up to approximately 194 days
|
|
Area under the plasma concentration-time curve (AUC) of ABBV-295
Délai: Up to approximately 194 days
|
AUC of ABBV-295 |
Up to approximately 194 days
|
|
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295
Délai: Up to approximately 194 days
|
AUCtau of ABBV-295 |
Up to approximately 194 days
|
|
Dose Normalized Cmax of ABBV-295
Délai: Up to approximately 194 days
|
Dose normalized Cmax of ABBV-295 will be assessed. |
Up to approximately 194 days
|
|
Dose Normalized AUC of ABBV-295
Délai: Up to approximately 194 days
|
Dose normalized AUC of ABBV-295 will be assessed. |
Up to approximately 194 days
|
|
Incidence of Anti-Drug Antibodies (ADAs)
Délai: Up to approximately 194 days
|
Incidence of ADAs will be assessed. |
Up to approximately 194 days
|
|
Percent Change in Body Weight From Baseline
Délai: Up to approximately 194 days
|
Percent change in body weight (kg) will be assessed. |
Up to approximately 194 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M26-089
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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