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
Overview
- Phase
- Phase 2
- Intervention
- MBL949
- Conditions
- Obesity
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Frequency and Severity of Adverse Events
- Status
- Terminated
- Last Updated
- last year
Overview
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 1 and a 10-week follow-up period. Participants were to be enrolled to: * MBL949 Arm 1, MBL949 Arm 2 and placebo in a 1:1:1 ratio * MBL949 Arm 3, MBL949 Arm 4 and placebo in a 1:1:1 ratio * If MBL949 Arm 1 was tolerated, MBL949 Arm 5 was enrolled with a 2:1 ratio (MBL:placebo) within each stratum.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
MBL949 Arm 1
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
Intervention: MBL949
MBL949 Arm 2
MBL949 two 3 mg doses followed by six doses of 4.5 mg
Intervention: MBL949
MBL949 Arm 3
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
Intervention: MBL949
MBL949 Arm 4
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
Intervention: MBL949
MBL949 Arm 5
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
Intervention: MBL949
Placebo
Placebo to MBL949
Intervention: Placebo
Outcomes
Primary Outcomes
Frequency and Severity of Adverse Events
Time Frame: Baseline to Day 169
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Change-from-baseline in Weight
Time Frame: Week 16
Baseline weight is defined as the last weight measurement before dosing in kilograms