Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)

Phase 2CompletedNCT07220629

Rezera (formerly NodThera Limited)82 enrolled

Overview

A Phase 2a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to explore the safety and efficacy of NT-0796 as an adjunct to semaglutide in participants with obesity over a 6 months treatment period.

Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomly assigned to receive the Investigational Medicinal Product (IMP, either NT-0796 or placebo) twice daily (BID). All participants will receive sc semaglutide. The IMP will be administered orally. Semaglutide will be initiated and titrated using a fixed, 4-weekly dose escalation scheme, as per the approved USPI. Following 32 weeks of active treatment, participants will enter a 4-week safety follow-up period before being discharged from the study. Semaglutide will be provided for the period from baseline (Day 1) up until completion of the 4-week safety follow-up. The Primary Endpoint of the study will be the safety and tolerability of NT-0796 as an adjunct to semaglutide, the key secondary endpoint will be the effect of NT-0796 as an adjunct to semaglutide on weight loss while secondary endpoints include percentage weight change from baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obesity

Interventions

NT-0796DRUG

Orally administered capsules

PlaceboDRUG

Orally administered capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female aged 18 to 75 years (inclusive) at Screening who have signed informed consent and are willing and able to comply with the study protocol. 2. Have a BMI of ≥30.0 kg/m2 and \<45.0 kg/m2 at Screening. (BMI values should be calculated to one decimal point precision and then assessed in terms of the required range). 3. History of at least one self-reported unsuccessful dietary effort to lose body weight. 4. Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI. Exclusion Criteria: 1. Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening. 2. Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide. 3. Type 1 or Type 2 Diabetes Mellitus (T1DM or T2DM), and/or HbA1c ≥6.5% (48 mmol/mol) at Screening and/or use of any anti-diabetic medications. 4. History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1. 5. History of acute coronary syndrome (ACS) including unstable angina, acute myocardial infarction (both ST segment elevation and non-ST segment elevation) within 6 months prior to Day 1.

Locations (9)

Investigative Site

Mesa, Arizona, United States

Investigative Site

Hialeah, Florida, United States

Investigative Site

Jacksonville, Florida, United States

Investigative Site

Miami, Florida, United States

Outcomes

Primary Outcomes

Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide in participants with obesity by assessing AEs and SAEs, symptoms of nausea and vomiting, clinical laboratory parameters, vital signs and ECGs.

Time frame: Baseline to Week 24

Secondary Outcomes

Ratio change from baseline to Week 20 in hsCRP

Time frame: Baseline to Week 20

Ratio change from baseline to Week 20 in Fibrinogen

Time frame: Baseline to Week 20

Percent change in body weight in participants with obesity

Time frame: Baseline to Week 20

Ratio change from baseline in hsCRP (mg/L)

Time frame: Weeks 4, 8, 12, 16, 24, 28, 32 and 36

Time-averaged ratio change from baseline in hsCRP (mg/L)

Time frame: Between weeks 4 and 32.

Time-to- achievement of hsCRP (mg/L) < 2, in the subset of subjects > 2 at baseline

Time frame: Baseline to Week 32

Ratio change from baseline in fibrinogen (mg/dL)

Time frame: Weeks 4, 8, 12, 16, 24, 28, 32 and 36

Percent change in body weight in participants with obesity

Time frame: Baseline to Weeks 4, 8, 12, 16, 24, 28, 32, 36

Change in waist circumference and waist/height ratio

Time frame: Baseline to Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36

Data from ClinicalTrials.gov

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