A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Clinical Pharmacology of Miami
Miami, Florida, United States
RECRUITINGSafety and tolerability
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From First Dose to Week 52
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - Cmax, MD
Maximum observed serum concentration after multiple doses (MD) (Cmax, MD)
Time frame: From First Dose to Week 52
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - AUC(0-τ), MD
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC(0-τ), MD)
Time frame: From First Dose to Week 52
Pharmacodynamic (PD) impact on body weight
Change from baseline in body weight
Time frame: Baseline, Week 32 and Week 52
Pharmacodynamic (PD) impact on body weight percentage
Change from baseline in body weight percentage
Time frame: Baseline, Week 32 and Week 52
Immunogenicity
Incidence of Anti-ALV-100 drug antibodies, including assessments of cross-reactivity and neutralizing antibodies.
Time frame: From Baseline to Week 52
Relationship between ALV-100 serum concentration and QTc interval changes (Part A Only)
Measurement of change in individual specific heart rate corrected QT interval (QTcI) and Fridericia heart rate corrected QT interval (QTcF) on 12-lead ECG.
Time frame: From First Dose to Week 52
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Paracetamol (acetaminophen) absorption test (PAT) (Part A Only)
Measurement of acetaminophen PK parameters to evaluate the effect of ALV-100 on the gastric emptying rate.
Time frame: From First Dose to Week 52
Pharmacodynamic (PD) impact of ALV-100 on antidiabetic medication (Part B Only)
Change in use of concomitant glucose-lowering medication
Time frame: From Baseline to Week 32
Pharmacodynamic (PD) impact of ALV-100 on glycemic parameters (Part B Only)
Measuring the number of participants achieving target Hemoglobin A1c values
Time frame: Week 32 and Week 52
Hypoglycemic Safety (Part B Only)
Measured by the incidence of symptomatic hypoglycemia, documented symptomatic hypoglycemia and severe hypoglycemia
Time frame: From Baseline to Week 52