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

NCT05199090 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CMBL949A122012021-004449-19
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

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.

Conditions

Obesity

Keywords

Type 2 diabetes mellitus; weight loss

Outcome Measures

Primary Outcomes (2)

• 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

• Change-from-baseline in Weight

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

  Week 16

Study Arms (6)

MBL949 Arm 1

ACTIVE COMPARATOR

MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg

Drug: MBL949

MBL949 Arm 2

ACTIVE COMPARATOR

MBL949 two 3 mg doses followed by six doses of 4.5 mg

Drug: MBL949

MBL949 Arm 3

ACTIVE COMPARATOR

MBL949 one 12 mg dose followed by seven doses of 4.5 mg

Drug: MBL949

MBL949 Arm 4

ACTIVE COMPARATOR

MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg

Drug: MBL949

MBL949 Arm 5

ACTIVE COMPARATOR

MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg

Drug: MBL949

Placebo

PLACEBO COMPARATOR

Placebo to MBL949

Drug: Placebo

Interventions

MBL949 DRUG

subcutaneous injections administered for 14 weeks

MBL949 Arm 1; MBL949 Arm 2; MBL949 Arm 3; MBL949 Arm 4; MBL949 Arm 5

Placebo DRUG

Placebo Comparator to MLB949

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Miami, Florida, 33135, United States

Location

Novartis Investigative Site

Morehead City, North Carolina, 28557, United States

Location

Novartis Investigative Site

Knoxville, Tennessee, 37920, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Related Links

• A Plain Language Trial Summary is available on novctrd.com

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 20, 2022
• Study Start: February 10, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: October 9, 2024
• Results First Posted: May 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (4)