NCT07220629

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
4mo left

Started Oct 2025

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2025Aug 2026

Study Start

First participant enrolled

October 2, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

October 17, 2025

Last Update Submit

April 2, 2026

Conditions

Obesity

Keywords

RESOLVE -2ObesityNLRP3NT-0796

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to Week 24

Secondary Outcomes (11)

  • Ratio change from baseline to Week 20 in hsCRP

    Baseline to Week 20

  • Ratio change from baseline to Week 20 in Fibrinogen

    Baseline to Week 20

  • Percent change in body weight in participants with obesity

    Baseline to Week 20

  • Ratio change from baseline in hsCRP (mg/L)

    Weeks 4, 8, 12, 16, 24, 28, 32 and 36

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

    Between weeks 4 and 32.

  • +6 more secondary outcomes

Study Arms (2)

Twice daily orally administered NT-0796 capsule

EXPERIMENTAL

Participants will receive study medication twice daily orally for up to 32 weeks, containing NT-0796 twice daily

Drug: NT-0796

Placebo orally administered capsule

PLACEBO COMPARATOR

Participants will receive placebo twice daily orally for up to 32 weeks

Drug: Placebo

Interventions

NT-0796DRUG

Orally administered capsules

Twice daily orally administered NT-0796 capsule
PlaceboDRUG

Orally administered capsules

Placebo orally administered capsule

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.
  • Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI.

You may not qualify if:

  • Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening.
  • Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide.
  • 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.
  • History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Investigative Site

Mesa, Arizona, 85225, United States

Location

Investigative Site

Hialeah, Florida, 33016, United States

Location

Investigative Site

Jacksonville, Florida, 32216, United States

Location

Investigative Site

Miami, Florida, 33147, United States

Location

Investigative Site

Marrero, Louisiana, 70006, United States

Location

Investigative Site

Columbus, Ohio, 43213, United States

Location

Investigative Site

Seabrook, Texas, 77586, United States

Location

Investigative Site

Salt Lake City, Utah, 84124, United States

Location

Investigative Site

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2025

First Posted

October 24, 2025

Study Start

October 2, 2025

Primary Completion (Estimated)

August 21, 2026

Study Completion (Estimated)

August 21, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(9)