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AzTrials

ObesityPhase 2GYMINDANCT06965413

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

A Phase 2 study testing RO7204239 and Tirzepatide in people with Obesity and Overweight, run by Hoffmann-La Roche at 35 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RO7204239 and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
35 sitesin 4 countries
Study dates
5 May 2025to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion)
  • BMI ≥ 27.0 kg/m² and < 30.0 kg/m² 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

Who cannot join

  • 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 screening
Show all 15Show fewer
  • Have a known clinically significant gastric emptying abnormality
  • Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)
  • Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening
  • Have evidence of a significant, uncontrolled endocrine abnormality
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy
  • Have evidence of a significant, active autoimmune abnormality
  • Have anemia
  • Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Trial locations and contacts

35 sites in 4 countries.

35 sites in 4 countries

United States19 sites

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731

  • Accellacare of Bristol/ Internal Medicine & Pediatrics

    Bristol, Tennessee, 37620

  • K2 Medical Research-Winter Garden

    Clermont, Florida, 34711

  • Juno Research, LLC

    Houston, Texas, 77040

  • Accellacare of Knoxville

    Knoxville, Tennessee, 37912

  • NexGen Research

    Lima, Ohio, 45801

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • Accellacare of Duly Health and Care

    Oak Lawn, Illinois, 60453

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Accellacare of Salisbury

    Salisbury, North Carolina, 28144

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas, 76710

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Spain6 sites

  • Hospital San Rafael A Coruna

    A Coruña, LA Coruna, 15006

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, Granada, 41950

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander, Cantabria, 39008

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, Barcelona, 41009

Other trials in Spain

United Kingdom6 sites

  • Fylde Coast Clinical Research at Layton Medical Centre

    Blackpool, Lancashire, FY3 7EN

  • Accellacare Warwickshire

    Coventry, CV3 4FJ

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester, Leicestershire, LE5 4PW

  • Accellacare North London

    Northwood, HA6 2RN

  • Accellacare South London

    Orpington, BR5 3QG

  • Accellacare Yorkshire

    Shipley, Yorkshire, BD18 3SA

Other trials in United Kingdom

Poland4 sites

  • Penta Hospials Badania Kliniczne Gdansk

    Gdansk, Pomeranian Voivodeship, 80-546

  • Centrum Medyczne ALL-MED

    Krakow, Lesser Poland Voivodeship, 30-033

  • Ekamed sp. z o.o.

    Lublin, 20-718

  • ETG Warszawa

    Warsaw, 02-677

Other trials in Poland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity

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). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.

Being tested
RO7204239, RO7204239 Matching Placebo, Tirzepatide
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7204239Drug

    RO7204239 or matching placebo will be administered as per the schedule specified in the arms.

  • RO7204239 Matching PlaceboDrug

    RO7204239 matching placebo will be administered as per the schedule specified in the arm.

  • TirzepatideDrug

    Tirzepatide will be administered as per the schedule specified in the arms.

Study groups in NCT06965413
Study groupRoleWhat they receive
Placebo + TirzepatideActive comparatorParticipants will receive RO7204239 matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for the core treatment period of 48 weeks and the treatment extension period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, every week (QW) during the core treatment period of 48 weeks.
Receives: Drug: RO7204239; Drug: RO7204239 Matching Placebo; Drug: Tirzepatide
RO7204239 low dose + TirzepatideExperimentalParticipants will receive RO7204239, low dose, SC, Q4W for the core treatment period of 48 weeks. During the treatment extension period participants will receive placebo for the period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks.
Receives: Drug: RO7204239; Drug: Tirzepatide
RO7204239 medium dose + TirzepatideExperimentalParticipants will receive RO7204239, medium dose, SC, Q4W for the core treatment period of 48 weeks. During the treatment extension period participants will receive placebo for the period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks.
Receives: Drug: RO7204239; Drug: Tirzepatide
RO7204239 high dose + TirzepatideExperimentalParticipants will receive RO7204239, high dose, SC, Q4W along with tirzepatide, given as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks. During the treatment extension period participants will be randomized to receive RO7204239 or matching placebo, SC, Q4W for 24 weeks.
Receives: Drug: RO7204239; Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight

    Measured: Baseline, Week 48

Secondary outcomes (25)

  1. Absolute Change From Baseline in Body Weight

    Measured: Baseline, Week 48

  2. Change From Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 48

  3. Change From Baseline in Waist-to-height Ratio

    Measured: Baseline, Week 48

  4. Change From Baseline in Waist Circumference

    Measured: Baseline, Week 48

  5. Change From Baseline in Total Body Fat Mass Measured by Dual-energy X-ray Absorptiometry (DXA)

    Measured: Baseline, Week 48

  6. Change From Baseline in Total Lean Body Mass Measured by DXA

    Measured: Baseline, Week 48

  7. Change From Baseline in Appendicular Lean Mass Measured by DXA at Week 48

    Measured: Baseline, Week 48

  8. Change From Baseline in Muscle Volume Measured by Magnetic Resonance Imaging (MRI)

    Measured: Baseline, Week 48

  9. Change From Baseline in Muscle Fat Infiltration Measured by MRI

    Measured: Baseline, Week 48

  10. Change From Baseline in Glycated Hemoglobin (HbA1C) Levels

    Measured: Baseline, Week 48

  11. Change From Baseline in Fasting Plasma Glucose Levels

    Measured: Baseline, Week 48

  12. Change From Baseline in Fasting C-peptide and Fasting Insulin Levels

    Measured: Baseline, Week 48

  13. Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Measured: Baseline, Week 48

  14. Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)

    Measured: Baseline, Week 48

  15. Change From Baseline in Fasting Lipid Profile

    Fasting lipid profile includes total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL cholesterol

    Measured: Baseline, Week 48

  16. Number of Participants With Adverse Events (AEs)

    Measured: Up to approximately 100 weeks

  17. Number of Participants With Local and Systemic Injection Reactions

    Measured: Up to approximately 100 weeks

  18. Serum Concentrations of RO7204239

    Measured: Up to approximately 96 weeks

  19. Steady-state Trough Concentration (Ctrough,ss) of RO7204239

    Measured: Up to approximately 96 weeks

  20. Half-life (t1/2) of RO7204239

    Measured: Up to approximately 96 weeks

  21. Steady-state Area Under the Concentration-time Curve Over One Dosing Interval (AUCtau,ss) of RO7204239

    Measured: Up to approximately 96 weeks

  22. Steady-state Maximum Concentration (Cmax,ss) of RO7204239

    Measured: Up to approximately 96 weeks

  23. Apparent Clearance (CL/F) of RO7204239

    Measured: Up to approximately 96 weeks

  24. Apparent Volume of Distribution (Vd/F) of RO7204239

    Measured: Up to approximately 96 weeks

  25. Number of Participants With Anti-drug Antibodies (ADAs) to RO7204239

    Measured: Up to approximately 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start5 May 2025
  3. Primary completion3 Sep 2026
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965413
Sponsor's protocol ID
BC45538
Other IDs
2024-519561-22-00
Acronym
GYMINDA
Status last verified
Sep 2026
First submitted
2 May 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO7204239 and Tirzepatide in people with Obesity and Overweight, run by Hoffmann-La Roche at 35 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Spain, United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight (time frame: Baseline, Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06965413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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