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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2023-05-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MBL949 Arm 1

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

Group Type ACTIVE_COMPARATOR

MBL949

Intervention Type DRUG

subcutaneous injections administered for 14 weeks

MBL949 Arm 2

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

Group Type ACTIVE_COMPARATOR

MBL949

Intervention Type DRUG

subcutaneous injections administered for 14 weeks

MBL949 Arm 3

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

Group Type ACTIVE_COMPARATOR

MBL949

Intervention Type DRUG

subcutaneous injections administered for 14 weeks

MBL949 Arm 4

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

Group Type ACTIVE_COMPARATOR

MBL949

Intervention Type DRUG

subcutaneous injections administered for 14 weeks

MBL949 Arm 5

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

Group Type ACTIVE_COMPARATOR

MBL949

Intervention Type DRUG

subcutaneous injections administered for 14 weeks

Placebo

Placebo to MBL949

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Comparator to MLB949

Interventions

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MBL949

subcutaneous injections administered for 14 weeks

Intervention Type DRUG

Placebo

Placebo Comparator to MLB949

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No