Clinical trial NCT05199090: Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Keywords: Type 2 diabetes mellitus
weight loss
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Frequency and Severity of Adverse Events
timeFrame: Baseline to Day 169
measure: Change-from-baseline in Weight
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Morehead City
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: