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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Obesity

Treatments: Drug: MBL949; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05199090

CMBL949A12201

2021-004449-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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126 participants in 6 patient groups, including a placebo group

MBL949 Arm 1

Active Comparator group

Description:

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

Treatment:

Drug: MBL949

MBL949 Arm 2

Active Comparator group

Description:

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

Treatment:

Drug: MBL949

MBL949 Arm 3

Active Comparator group

Description:

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

Treatment:

Drug: MBL949

MBL949 Arm 4

Active Comparator group

Description:

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

Treatment:

Drug: MBL949

MBL949 Arm 5

Active Comparator group

Description:

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

Treatment:

Drug: MBL949

Placebo

Placebo Comparator group

Description:

Placebo to MBL949

Treatment:

Drug: Placebo