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Tests treatment safety and results for Weight Management
Official title A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
ClinicalTrials.gov ID: NCT07667803
What this study is testing
What is Elecoglipron?
Elecoglipron is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for weight management.
Also referred to as Active IMP.
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
- This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Legal age of consent and at least 18 years old
- Study 1 -
- BMI ≥ 30 kg/m2 or
- 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities:
- Hypertension
You likely can't join if
- Study 1 - Established diagnosis of T1DM or T2DM.
- Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
- T1DM
- HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or...
See the full eligibility criteria
- Legal age of consent and at least 18 years old
- Study 1 -
- BMI ≥ 30 kg/m2 or
- 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities:
- Hypertension
- Prediabetes
- Dyslipidemia
- Cardiovascular disease
- Obstructive sleep apnea.
- Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:
- Established diagnosis of T2DM
- Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
- Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Study 1 - Established diagnosis of T1DM or T2DM.
- Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
- T1DM
- HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
- History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Dothan, Alabama, United States
- Chandler, Arizona, United States
- Peoria, Arizona, United States
- Little Rock, Arkansas, United States
- Lynwood, California, United States
- Rolling Hills Estates, California, United States
- Sacramento, California, United States
- Arvada, Colorado, United States
- New Haven, Connecticut, United States
- Clearwater, Florida, United States
- Plantation, Florida, United States
- Woodstock, Georgia, United States
- Ammon, Idaho, United States
- Melrose Park, Illinois, United States
- Indianapolis, Indiana, United States
- Wichita, Kansas, United States
- Louisville, Kentucky, United States
- Alexandria, Louisiana, United States
- Baltimore, Maryland, United States
+ 249 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Birmingham, Alabama, United States; Dothan, Alabama, United States; Chandler, Arizona, United States; Peoria, Arizona, United States; Little Rock, Arkansas, United States; Lynwood, California, United States and 263 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.