RightFit
RecruitingPhase 2

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

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 to 75 Years
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 how safe different study treatments are and how well they help with long-term weight control. It is for adults with obesity or overweight. Each treatment is tested in a separate part of the study.

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

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

Eligibility

Who can join

  • Meet the BMI rules. BMI compares weight with height. The listing gives a BMI of 30 or higher, or 27 to under 30. It also mentions a weight-related health problem, but does not clearly say when this is required.
  • Have a steady weight for the 3 months before being assigned to a treatment group, with less than a 5% weight gain or loss.

Who can't join

  • Have had or plan to have weight-loss surgery. Liposuction or a tummy tuck is allowed if done more than 1 year before screening.
  • Have type 1 diabetes or autoimmune diabetes that starts in adults. Also excluded: a history of ketoacidosis (dangerous acid buildup in the blood) or hyperosmolar coma (coma linked to very high blood sugar).
  • Have high blood pressure that is not well controlled.
  • Have signs or symptoms of liver disease, except fatty liver disease not caused by alcohol.
  • Within 3 months before screening, had a heart attack, stroke, unstable angina (new or worsening chest pain), or a hospital stay for heart failure.
  • Have had gallbladder disease with symptoms in the past 2 years.
  • Have ever attempted suicide.

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

Official eligibility criteria

Inclusion Criteria: * Have a body mass index (BMI) * ≥30 kilogram/square meter (kg/m²), or * ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity * Have had a stable body weight for the 3 months prior to randomization (\<5%) body weight gain and/or loss. Exclusion Criteria: * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * Have poorly controlled hypertension. * Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure. * Have a history of symptomatic gallbladder disease within the past 2 years. * Have a lifetime history of suicide attempts.

Study sites (50)

AZ

CA

CT

FL

HI

IA

ID

IL

KS

KY

MA

MI

  • Headlands Research - Detroit · Southfield, MI 48034Christopher Romero · Principal investigatorMore trials in Southfield
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division · Troy, MI 48098 · Study contact · 248-312-0025Neil Fraser · Principal investigatorMore trials in Troy

MO

NC

NV

NY

OH

SC

TN

TX

VA

WA

  • Central Washington Health Services Association d/b/a Confluence Health · Wenatchee, WA 98801 · Study contact · 509-436-4050Kathryn Eren · Principal investigatorMore trials in Wenatchee