Obesity Clinical Trial
Official title:
A Randomized, Placebo-controlled, Participant-and-investigator- Blinded, Sponsor Open-label Study to Evaluate the Safety, Tolerability, and Efficacy With Different Dosing Regimens of Subcutaneously Administered MBL949 in Obese Participants With or Without Type 2 Diabetes Mellitus
Verified date | August 2023 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.
Status | Completed |
Enrollment | 126 |
Est. completion date | May 11, 2023 |
Est. primary completion date | May 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Body mass index: = 32 kg/m2, weight = 77 kg, stable body weight i.e., less than 1.5 kg self-reported change within 90 days - Diagnosed T2DM as documented by medical history and confirmed by Investigator and with diagnosed duration < 10 yrs, HbA1c = 9%, and fasting C-peptide = 0.2 ng/ml - If treated for T2DM, treatment must be limited to diet and exercise and treatment with one of the following anti-diabetic agents (stable for 90 days prior to randomization): - Metformin - SGLT2i inhibitors (if prescribed as the first line, ie. single agent) - DDP4 inhibitors - Acarbose Exclusion Criteria: - Vitals at screening: - systolic blood pressure less than 95 mm Hg or greater than 155 mm Hg - diastolic blood pressure less than 60 mg Hg or greater than 95 mm Hg - pulse rate less than 56 or greater than 110 bpm - History of bariatric surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening - History of myocardial infarction with 2 years of screening - Diet attempts within 90 days before screening - Participation in organized weight reduction program within 6 months of screening |
Country | Name | City | State |
---|---|---|---|
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Knoxville | Tennessee |
United States | Novartis Investigative Site | Miami Beach | Florida |
United States | Novartis Investigative Site | Morehead City | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of Adverse Events | Primary endpoints for safety and tolerability are occurrences and severities of adverse events by number and percentage of participants reported after the first dose of study medication or events present prior to treatment but increase in severity | Baseline to Day 169 | |
Primary | Change-from-baseline in weight | Baseline weight is defined as the last weight measurement before dosing in kilograms | Week 16 |
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