Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
GLP-1, Metsera, T2DM, Obesity, Overweight, Weight Loss
Brief summary
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.
Detailed description
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.
Interventions
DRUGMET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
DRUGPlacebo
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening * Type 2 diabetes mellitus (\*T2DM) for at least 3 months before screening * Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2) * Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening
Exclusion criteria
* Female who is lactating or who is pregnant * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 * Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL) * Poorly controlled hypertension * History of stroke * Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure * Diagnosis of Type 1 diabetes (history of ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM) * History of acute or chronic pancreatitis * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Relevant surgical history including all bariatric or weight loss surgeries * SGLT2 inhibitors and/or metformin * Had 1 or more episodes of hypoglycemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight at Week 28 (Day 197) | Baseline (Week 0) through Week 28 (Day 197) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight reduction (weight loss) from baseline that is ≥ 5% | Baseline (Week 0) through Week 28 (Day 197) | — |
| Weight reduction (weight loss) from baseline that is ≥ 10% | Baseline (Week 0) through Week 28 (Day 197) | — |
| Weight reduction (weight loss) from baseline that is ≥ 15% | Baseline (Week 0) through Week 28 (Day 197) | — |
| Change in glycated hemoglobin A1c (HbA1c) | Baseline (Week 0) through Week 28 (Day 197) | — |
| Change from baseline in fasting plasma glucose (FPG) | Baseline (Week 0) through Week 28 (Day 197) | — |
| Change from baseline in fasting serum insulin | Baseline (Week 0) through Week 28 (Day 197) | — |
| Change from baseline in C-peptide | Baseline (Week 0) through Week 28 (Day 197) | — |
| Occurrence of HbA1c <7.0% (53.0 mmol/mol) | Baseline (Week 0) through Week 28 (Day 197) | — |
| Occurrence of HbA1c ≤6.5% (47.5 mmol/mol) | Baseline (Week 0) through Week 28 (Day 197) | — |
| Occurrence of HbA1c <5.7% (38.8 mmol/mol) | Baseline (Week 0) through Week 28 (Day 197) | — |
| Occurrence of treatment-emergent adverse events (TEAEs) | Baseline (Week 0) through Week 39 (Day 274) | 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. |
| Occurrence of hypoglycemia according to American Diabetes Association classifications [ADA 2024] | Baseline (Week 0) through Week 39 (Day 274) | — |
| Occurrence of anti-drug antibodies | Baseline (Week 0) through Week 39 (Day 274) | — |
| Change from baseline in serum albumin | Baseline (Week 0) through Week 39 (Day 274) | — |
| Change from baseline in transthyretin [pre-albumin] | Baseline (Week 0) through Week 39 (Day 274) | — |
| Change from baseline in high-sensitivity C-reactive Protein [hsCRP] | Baseline (Week 0) through Week 39 (Day 274) | — |
| Characterize the minimum observed concentration (Cmin) | Baseline (Week 0) through Week 39 (Day 274) | — |
| Characterize the maximum observed concentration (Cmax) | Baseline (Week 0) through Week 39 (Day 274) | — |
| Characterize the area under the concentration versus time curve (AUC) | Baseline (Week 0) through Week 39 (Day 274) | — |
| Characterize the time to maximum concentration (Tmax) | Baseline (Week 0) through Week 39 (Day 274) | — |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed