En studie av ABBV-295 subkutana injektioner för att bedöma biverkningar och farmakokinetik hos vuxna deltagare med fetma
En fas 1b-studie för att bedöma säkerhet, tolerabilitet, farmakokinetik, immunogenicitet och farmakodynamik av flera subkutana doser av ABBV-295 hos vuxna försökspersoner med fetma
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
California
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Anaheim, California, Förenta staterna, 92801
- CenExel Act- Anaheim Clinical Trials /ID# 283200
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Illinois
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Grayslake, Illinois, Förenta staterna, 60030
- Acpru /Id# 278624
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Experimentell: ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Experimentell: ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Experimentell: 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 |
|
Experimentell: ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Experimentell: 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 |
|
Experimentell: ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
Experimentell: ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 194 days
|
Cmax of ABBV-295 |
Up to approximately 194 days
|
|
Time to Cmax (Tmax) of ABBV-295
Tidsram: Up to approximately 194 days
|
Tmax of ABBV-295 |
Up to approximately 194 days
|
|
Trough plasma concentration (Ctrough) of ABBV-295
Tidsram: Up to approximately 194 days
|
Ctrough of ABBV-295 |
Up to approximately 194 days
|
|
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
Tidsram: Up to approximately 194 days
|
BETA of ABBV-295 |
Up to approximately 194 days
|
|
Terminal phase elimination half-life (t1/2) of ABBV-295
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 194 days
|
AUCtau of ABBV-295 |
Up to approximately 194 days
|
|
Dose Normalized Cmax of ABBV-295
Tidsram: 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
Tidsram: 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)
Tidsram: Up to approximately 194 days
|
Incidence of ADAs will be assessed. |
Up to approximately 194 days
|
|
Percent Change in Body Weight From Baseline
Tidsram: Up to approximately 194 days
|
Percent change in body weight (kg) will be assessed. |
Up to approximately 194 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: ABBVIE INC., AbbVie
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M26-089
Plan för individuella deltagardata (IPD)
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