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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05199090
• Other study ID #: CMBL949A12201
• Secondary ID: 2021-004449-19
• Status: Terminated
• Phase: Phase 2
• Start date: February 10, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• 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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Morehead City	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and Severity of Adverse Events	Number of participants with adverse events 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