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

• ClinicalTrials.gov Identifier: NCT05199090
• Recruitment Status: Completed
• First Posted: January 20, 2022
• Last Update Posted: August 22, 2023
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: MBL949; Drug: Placebo	Phase 2

Detailed Description:

The study comprises a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants will be administered MBL949 or placebo at 8 biweekly intervals starting on Day 1 and a 10-week follow-up period

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 10, 2022
• Actual Primary Completion Date: May 11, 2023
• Actual Study Completion Date: May 11, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: MBL949 Arm 1; One dose C followed by two doses E followed by five doses D of MBL949	Drug: MBL949; subcutaneous injections administered for 14 weeks
Active Comparator: MBL949 Arm 2; Two doses C followed by six doses D of MBL949	Drug: MBL949; subcutaneous injections administered for 14 weeks
Active Comparator: MBL949 Arm 3; One dose G followed by seven doses D of MBL949	Drug: MBL949; subcutaneous injections administered for 14 weeks
Active Comparator: MBL949 Arm 4; One dose A followed by seven doses B of MBL949	Drug: MBL949; subcutaneous injections administered for 14 weeks
Active Comparator: MBL949 Arm 5; One dose C followed by two doses E followed by five doses F of MBL949	Drug: MBL949; subcutaneous injections administered for 14 weeks
Placebo Comparator: Placebo; MBL949 Arm 1, MBL949 Arm 2 and placebo to be enrolled in a 1:1:1 ratio MBL949 Arm 3, MBL949 Arm 4 and placebo to be enrolled in a 1:1:1 ratio If MBL949 Arm 1 is tolerated, MBL949 Arm 5 to be enrolled with a 2:1 ratio (MBL:placebo) within each stratum. MBL949 arm 5 will have 12 participants and 6 participants added to placebo arm	Drug: Placebo; Placebo Comparator to MLB949

Outcome Measures

Primary Outcome Measures :

1. Frequency and severity of Adverse Events [ Time Frame: Baseline to Day 169 ]
   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
2. Change-from-baseline in weight [ Time Frame: Week 16 ]
   Baseline weight is defined as the last weight measurement before dosing in kilograms

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Novartis Investigative Site

Miami Beach, Florida, United States, 33140

United States, North Carolina

Novartis Investigative Site

Morehead City, North Carolina, United States, 28557

United States, Tennessee

Novartis Investigative Site

Knoxville, Tennessee, United States, 37920

United States, Texas

Novartis Investigative Site

Dallas, Texas, United States, 75230

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05199090
• Other Study ID Numbers: CMBL949A12201; 2021-004449-19 ( EudraCT Number )
• First Posted: January 20, 2022
• Last Update Posted: August 22, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Type 2 diabetes mellitus; weight loss