RightFit
RecruitingPhase 2

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes

A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests olatorepatide, an experimental drug, in adults with overweight or obesity who do not have diabetes. It compares the drug with a placebo (a treatment with no active drug) to see how safe it is and how well it works at different doses and schedules. It also checks how the body handles the drug and whether it makes antibodies that may make the drug work less well.

This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much study drug is in the blood at different times * How well the study drug works * What effects the study drug may have on the body at different dosing schedules * If the body makes antibodies to the study drug as this may cause the study drug to not work as well

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must meet one of the two weight rules below. BMI is a measure based on height and weight.
  • Have a BMI of 30 or higher but less than 45 at the screening visit.
  • OR have a BMI of 27 or higher and at least one listed weight-related health problem: high blood pressure, unhealthy blood fat levels, prediabetes (blood sugar above normal), sleep apnea (breathing stops and starts during sleep), disease in the heart’s arteries, heart failure, or disease of blood vessels in the brain.
  • Other study rules also apply.

Who can't join

  • Have ever been diagnosed with type 1 or type 2 diabetes.
  • Your weight changed by more than 5 kg (about 11 pounds) in about the 3 months before screening.
  • Have had weight-loss surgery, including surgery to change, undo, or remove an earlier weight-loss procedure.
  • Have had pancreatitis (swelling of the pancreas), cholecystitis (swelling of the gallbladder), or gallstones that caused symptoms.
  • You or a family member have had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in glands that make hormones.
  • Other study rules also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. Body Mass Index (BMI) ≥30.0 kg/m\^2 to \<45.0 kg/m\^2 at screening OR 2. BMI ≥27.0 kg/m\^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol Key Exclusion Criteria: 1. Previous or current diagnosis of Type 1 or Type 2 diabetes at screening 2. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol 3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol 4. History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones 5. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study sites (21)

AL

CA

CT

FL

IL

KS

KY

NE

NY

SC