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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05199090
• Collaborator: (none)
• Enrollment: 106
• Locations: 4
• Arms: 6
• Anticipated Duration (Months): 13.5
• Patients Per Site: 26.5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obesity	Drug: MBL949; Drug: Placebo	Phase 2

Detailed 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 T2DM on weight loss.

Eligible participants will be evaluated for status of glucose homeostasis for stratified enrolment based on whether they are normoglycemic, have impaired glucose tolerance or T2DM.

Participants will be randomized to one of five MBL949 arms or placebo, administered by subcutaneous (SC) injection during the treatment period:

MBL949 Arm 1: One dose C followed by two doses E followed by five doses D of MBL949 Arm 2:

Two doses C followed by six doses D of MBL949 Arm 3: One dose G followed by seven doses D of MBL949 Arm 4: One dose A followed by seven doses B of MBL949 Arm 5: One dose C followed by two doses E followed by five doses F of MBL949.

Participants will be evaluated for safety, tolerability, efficacy, and PK during the treatment and follow-up period

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 106 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: Feb 10, 2022
• Anticipated Primary Completion Date: Mar 28, 2023
• Anticipated Study Completion Date: Mar 28, 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 [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 [Week 16]

   Baseline weight is defined as the last weight measurement before dosing in kilograms

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Miami Beach	Florida	United States	33140
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

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05199090
• Other Study ID Numbers: CMBL949A12201; 2021-004449-19
• First Posted: Jan 20, 2022
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Type 2 diabetes mellitus; weight loss

Study Results

No Results Posted as of Apr 7, 2022