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New treatment option for Obesity
Official title A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
ClinicalTrials.gov ID: NCT07400653
What this study is testing
What is PF-08653944?
PF-08653944 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Also referred to as MET097.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight.
- Phase 3: a large, late-stage study
- Time commitment: about 21 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form (ICF)
- Male or female adults, aged ≥18 years
- Have a BMI at Screening of ≥27.0 kg/m2
- Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
- Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to...
You likely can't join if
- Female who is breastfeeding, or who is pregnant
- Unwilling or unable to follow contraceptive requirements
- Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.
- Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening
- Poorly controlled hypertension
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
See the full eligibility criteria
- Provision of signed and dated informed consent form (ICF)
- Male or female adults, aged ≥18 years
- Have a BMI at Screening of ≥27.0 kg/m2
- Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
- Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with: --Diet and exercise alone or in...
- Participants must be motivated and willing to:
- Self-inject study medication (or be aided by caregiver if needed),
- Perform finger-stick glucose monitoring as required.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Female who is breastfeeding, or who is pregnant
- Unwilling or unable to follow contraceptive requirements
- Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.
- Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening
- Poorly controlled hypertension
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
- Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss
- Are receiving or have received within 3 months prior to screening chronic (\>2 weeks or 14 days) systemic glucocorticoid therapy
The study team makes the final eligibility decision.
Where it's taking place
- Anaheim, California, United States
- Canoga Park, California, United States
- Cerritos, California, United States
- Los Alamitos, California, United States
- Montclair, California, United States
- Orange, California, United States
- Riverside, California, United States
- Torrance, California, United States
- Englewood, Colorado, United States
- Fort Myers, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Longwood, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orange City, Florida, United States
- Oviedo, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
+ 126 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 21 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anaheim, California, United States; Canoga Park, California, United States; Cerritos, California, United States; Los Alamitos, California, United States; Montclair, California, United States; Orange, California, United States and 140 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.