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Completed

NCT Number: NCT06277934

A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities

The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Velocity Clinical Research, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years
  • Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
  • Have had a stable body weight for the 3 months prior to randomization

Exclusion criteria

  • Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
  • Have a prior or planned surgical treatment for obesity
  • Have or plan to have endoscopic and/or device-based therapy for obesity
  • Have any prior diagnosis of diabetes
  • Have an electrocardiogram (ECG) with abnormalities
  • Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
  • Have a history of suicide attempt.

Treatment and study plan

RGT001-075

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings

    Time frame: 14 weeks

Secondary outcomes

  1. Percent change in body weight

    Time frame: 12 weeks

    Percent change in body weight from baseline at Week 12

  2. Change in body weight in kilogram

    Time frame: 12 weeks

    Change in body weight from baseline at Week 12

  3. Percentage of participants who achieve ≥5% and ≥10% body weight reduction

    Time frame: 12 weeks

    Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12

  4. Change in Body mass index (BMI) in kg/m^2

    Time frame: 12 weeks

    Change in BMI from baseline at Week 12

  5. Change in waist circumference in centimetre

    Time frame: 12 weeks

    Change in waist circumference from baseline at Week 12 .

  6. RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)

    Time frame: 12 weeks

    Analysis of AUC0-last

  7. RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)

    Time frame: 12 weeks

    Analysis of AUC0-inf

  8. RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)

    Time frame: 12 weeks

    Analysis of Cmax

  9. RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)

    Time frame: 12 weeks

    Analysis of Tmax

  10. RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)

    Time frame: 12 weeks

    Analysis of t1/2

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Regor Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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