Health TrialsbyHealthPanel

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

ConditionObesity and Overweight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to <30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

Disqualifiers

Have any form of diabetes

Have a self-reported body weight change > 5 kg (11 pounds) within 3 months prior to Screening

Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • MET097

    Drug

    Once-weekly MET097 administered via subcutaneous injection

  • Placebo

    Drug

    Once-weekly placebo administered via subcutaneous injection

Treatment groups

3,501 Participants
are divided into 4 treatment groups
Group A: MET097 Dose 1Experimental treatment 1 intervention
Group B: MET097 Dose 2Experimental treatment 1 intervention
Group C: MET097 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in body weight

Time frame
Baseline (Day 0) to Week 64

Secondary outcomes

1

Percentage of Participants who achieve ≥5% of reduction from baseline body weight

Time frame
Baseline (Day 0) to Week 64
2

Percentage of Participants who achieve ≥10% of reduction from baseline body weight

Time frame
Baseline (Day 0) to Week 64
3

Percentage of Participants who achieve ≥15% of reduction from baseline body weight

Time frame
Baseline (Day 0) to Week 64
4

Percentage of Participants who achieve ≥20% of reduction from baseline body weight

Time frame
Baseline (Day 0) to Week 64

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
Apply now