Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM

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

ClinicalTrials.gov Identifier: NCT05199090

Novartis Reference Number: CMBL949A12201

Last Update: Apr 07, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics (PK) of subcutaneous (SC) MBL949 in obese participants with or without type 2 diabetes mellitus (T2DM) on weight loss.

Condition 
Obesity
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Feb 10, 2022
Completion date 
Mar 28, 2023
Gender 
All
Age(s)
18 Years - 60 Years (Adult)

Interventions

Drug
MBL949
subcutaneous injections administered for 14 weeks
Drug
Placebo
Placebo Comparator to MLB949

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
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

Study Locations

United States
Novartis Investigative Site
Recruiting
Miami Beach, 33140
Florida
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Novartis Investigative Site
Recruiting
Knoxville, 37920
Tennessee
United States
Novartis Investigative Site
Recruiting
Dallas, 75230
Texas
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]