A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPfizer
About this trial
This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts G.
Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
Disqualifiers
Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with protocol-specified contraceptive requirements.
Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.
Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
Trial design
Design model
Sequential
Treatments tested in this trial
MET233 and MET097
DrugFor subcutaneous administration
Placebo
Other interventionSterile 0.9% (w/v) saline for subcutaneous administration.
MET097
DrugFor subcutaneous administration
Treatment groups
381 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Part A CohortExperimental treatment 2 interventions
Group B: Part B CohortExperimental treatment 2 interventions
Group C: Part C CohortExperimental treatment 2 interventions
Group D: Part D CohortExperimental treatment 2 interventions
Group E: Part E CohortExperimental treatment 2 interventions
Group F: Part G CohortExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Occurrence of treatment-emergent adverse events (TEAEs)
For Part A, B, C, D, E and G
Time frame
Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)Secondary outcomes
1
Area under the concentration versus time curve extrapolated to infinity (AUCinf)
For Part A
Time frame
Part A (Baseline, Day 85)2
Area under the concentration versus time curve during the dosing interval (AUCtau)
For Part B, C, D, E, and G
Time frame
Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)3
Minimum observed concentration (Cmin)
For Part B, C, D, E, and G
Time frame
Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)4
Maximum observed concentration (Cmax)
For Part A, B, C, D, E, and G
Time frame
Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274) Source ClinicalTrials.gov