Status:
TERMINATED
Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.
Detailed Description
The study comprised a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants were administered MBL949 or placebo at 8 biweekly intervals starting on Day...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05199090
Start Date
February 10 2022
End Date
May 11 2023
Last Update
October 9 2024
Active Locations (4)
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1
Novartis Investigative Site
Miami, Florida, United States, 33135
2
Novartis Investigative Site
Morehead City, North Carolina, United States, 28557
3
Novartis Investigative Site
Knoxville, Tennessee, United States, 37920
4
Novartis Investigative Site
Dallas, Texas, United States, 75230