Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

Key Inclusion Criteria:

- A written informed consent must be obtained before any study-related assessments are
performed.

- Men and women between 18 and 80 years, inclusive; women of child-bearing potential
(defined as those who are not post-menopausal or post-surgical sterilization) must
meet both of the following criteria:

- Two negative pregnancy tests (at screening and at randomization, prior to
dosing)

- Use of intrauterine device, from at least 3 months before the baseline visit
through at least 4 months after the last dose of bimagrumab/placebo i.v., and
an additional contraceptive (barrier) method from screening through at least 4
months after the last dose of bimagrumab/placebo i.v.

- Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated
comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)

- Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg

- Have a history of at least one self-reported unsuccessful behavioral effort to lose
body weight

- Able to communicate well with the Investigator, comply with the study requirements
and adhere to the diet and activity programs for the study duration

Key Exclusion Criteria:

- History of, or known hypersensitivity to, monoclonal antibody drugs or a
contraindication to semaglutide (Ozempic® or Wegovy®)

- Use of other investigational drugs at the time of enrollment or within 30 days or 5
half-lives of enrollment, whichever is longer, or longer if required by local
regulations

- Treatment with any medication for the indication of obesity within the past 30 days
before screening

- Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5%
Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic
drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired
glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet
and exercise) is not an exclusion.

- Any chronic infections likely to interfere with study conduct or interpretation such
as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV).
History of hepatitis A or hepatitis C successfully treated is not exclusionary.
Active COVID-19 infection.

- Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing,
or longer if required by local regulation, or plasma donation (> 250 mL) within 14
days prior to the first dose

- Any disorder, unwillingness, or inability not covered by any of the other exclusion
criteria, which in the Investigator's opinion, might jeopardize the participant's
safety or compliance with the protocol