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NCT06965413RECRUITINGIRB Ready

A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity

(GYMINDA)

Sponsored by Hoffmann-La Roche

Quick Self-Assessment

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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM).

Who Can Participate

Inclusion Criteria

BMI โ‰ฅ 30.0 kilograms per square meter (kg/mยฒ) (additional weight-related comorbidities are not required for inclusion)
BMI โ‰ฅ 27.0 kg/mยฒ and \< 30.0 kg/mยฒ with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovascular disease
History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight
Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening

Exclusion Criteria

Prior history or diagnosis of DM
Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema
Have obesity induced by other endocrinologic disorders
Participation in unbalanced/extreme diets
Prior or planned surgical treatment for obesity
Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to scr

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

234 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Hoffmann-La Roche

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Anniston

Alabama

Location available
View Anniston location page
Unknown

Spring Valley

California

Location available
View Spring Valley location page
Unknown

Orlando

Florida

Location available
View Orlando location page
Unknown

Union City

Georgia

Location available
View Union City location page
Unknown

Oak Lawn

Illinois

Location available
View Oak Lawn location page
Unknown

Rochester

New York

Location available
View Rochester location page
Unknown

Salisbury

North Carolina

Location available
View Salisbury location page
Unknown

Statesville

North Carolina

Location available
View Statesville location page
Unknown

Wilmington

North Carolina

Location available
View Wilmington location page

๐Ÿ“ And 10 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Obesity Treatment in Anniston?

Join others in Alabama exploring innovative treatment options through clinical research

Obesity Treatment Options in Anniston, Alabama

If you're searching for Obesity treatment in Anniston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Anniston, Spring Valley, Waterbury and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Obesity. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 234 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Obesity?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Obesity

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Obesity Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06965413. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.