A Phase 2 interventional study of MET097 Injection and Placebo in Obesity in Diabetes and Type 2 Diabetes Mellitus (T2DM), sponsored by Pfizer. Completed at 29 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.
This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index [BMI] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 11 weeks after administration of the last dose of study treatment.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 133 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MET097 Injection
Drug: Placebo
Drug: MET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
Percent change from baseline in body weight at Week 28 (Day 197)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 5%
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 10%
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 15%
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change in glycated hemoglobin A1c (HbA1c)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in fasting serum insulin
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in C-peptide
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Occurrence of HbA1c <7.0% (53.0 mmol/mol)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Occurrence of HbA1c ≤6.5% (47.5 mmol/mol)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Occurrence of HbA1c <5.7% (38.8 mmol/mol)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Occurrence of treatment-emergent adverse events (TEAEs)
Treatment emergent adverse events include adverse events of clinical interest as well as abnormal clinical significant physical exams, laboratory findings, and 12-lead ECG measurements that meet the definition for an AE.
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Occurrence of hypoglycemia according to American Diabetes Association classifications [ADA 2024]
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Occurrence of anti-drug antibodies
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Change from baseline in serum albumin
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Change from baseline in transthyretin [pre-albumin]
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Change from baseline in high-sensitivity C-reactive Protein [hsCRP]
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Characterize the minimum observed concentration (Cmin)
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Characterize the maximum observed concentration (Cmax)
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Characterize the area under the concentration versus time curve (AUC)
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Characterize the time to maximum concentration (Tmax)
Time frame: Baseline (Week 0) through Week 39 (Day 274)
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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