A Phase 2 interventional study of Apitegromab and Placebo in Overweight and Obesity, sponsored by Scholar Rock, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Scholar Rock, Inc. · Phase 2, Interventional, and Treatment
A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight or obesity
This phase 2 randomized, double-blind, placebo-controlled, multicenter study assessed the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight and obesity and without diabetes. Each subject received tirzepatide throughout the treatment period. In addition, all subjects were randomized 1:1 to receive either apitegromab or placebo during the treatment period.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 102 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Scholar Rock, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At Screening, a of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apitegromab + incretin mimetic
Drug: Apitegromab · Drug: Tirzepatide
Placebo + incretin mimetic
Drug: Placebo · Drug: Tirzepatide
Apitegromab (SRK-015) is a fully human anti-proMyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab was administered every 4 weeks by intravenous (IV) infusion.
Also known as: SRK-015
Same appearance and composition as apitegromab drug product but does not contain the active ingredient. Placebo was administered every 4 weeks by intravenous (IV) infusion.
Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide was administered every week by subcutaneous injection.
Also known as: ZEPBOUND
Change from Baseline in total Lean Body Mass (kg) at 24 weeks
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Change from Baseline in body weight
Total body weight was assessed via a calibrated scale
Time frame: Baseline and 24 weeks
Change from Baseline in percent lean body mass (%)
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Change from Baseline in fat body mass (kg and %)
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Percent (%) of weight loss from baseline due to fat body mass loss
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Percent (%) of weight loss from baseline due to lean body mass loss
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Concentration of apitegromab in circulation over time
Blood samples were assessed for circulating concentration of apitegromab
Time frame: Baseline up to 40 weeks
Concentration of latent myostatin in circulation over time
Blood samples were assessed for circulating concentration of latent myostatin
Time frame: Baseline up to 24 weeks
Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence and severity of TEAEs and SAEs
Time frame: Baseline up to 40 weeks
Presence of anti-drug antibodies (ADA) against apitegromab over time
Measured in serum blood samples
Time frame: Baseline up to 40 weeks
Change from Baseline in HbA1c
Blood samples were assessed for HbA1c (glycated hemoglobin)
Time frame: Baseline up to 32 weeks
Change from baseline in fasting serum triglycerides
Blood samples were assessed for fasting serum triglycerides
Time frame: Baseline up to 32 weeks
Change from baseline in total cholesterol
Blood samples were assessed for total cholesterol
Time frame: Baseline up to 32 weeks
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
Blood samples were assessed for low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline up to 32 weeks
Plan to share: Yes
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Apitegromab
Scholar Rock, Inc.